Trial Outcomes & Findings for Phase 2 Clinical Trial to Evaluate OC-01 Nasal Spray in Subjects With Neurotrophic Keratopathy (NCT NCT04957758)
NCT ID: NCT04957758
Last Updated: 2024-05-07
Results Overview
Corneal Fluorescein Staining was measured utilizing the Modified Oxford Grading scale. Scores range from a minimum of 0 (no staining) to a maximum of 5. A higher score indicates a worse outcome. The study eye is defined as the eye with the worst staining grade (if both eyes are eligible).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
113 participants
Primary outcome timeframe
8 weeks
Results posted on
2024-05-07
Participant Flow
Participant milestones
| Measure |
OC-01 (Varenicline) Nasal Spray, 1.2 mg/mL
OC-01 (varenicline) nasal spray, 1.2 mg/mL
OC-01 (varenicline) nasal spray 1.2 mg/ml: OC-01
|
Placebo (Vehicle Control) Nasal Spray
Placebo (vehicle control) nasal spray
Placebo (vehicle) nasal spray: Placebo (vehicle)
|
|---|---|---|
|
Overall Study
STARTED
|
53
|
60
|
|
Overall Study
COMPLETED
|
48
|
55
|
|
Overall Study
NOT COMPLETED
|
5
|
5
|
Reasons for withdrawal
| Measure |
OC-01 (Varenicline) Nasal Spray, 1.2 mg/mL
OC-01 (varenicline) nasal spray, 1.2 mg/mL
OC-01 (varenicline) nasal spray 1.2 mg/ml: OC-01
|
Placebo (Vehicle Control) Nasal Spray
Placebo (vehicle control) nasal spray
Placebo (vehicle) nasal spray: Placebo (vehicle)
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
4
|
2
|
|
Overall Study
Protocol Violation
|
0
|
1
|
Baseline Characteristics
Phase 2 Clinical Trial to Evaluate OC-01 Nasal Spray in Subjects With Neurotrophic Keratopathy
Baseline characteristics by cohort
| Measure |
OC-01 (Varenicline) Nasal Spray, 1.2 mg/mL
n=53 Participants
OC-01 (varenicline) nasal spray, 1.2 mg/mL
OC-01 (varenicline) nasal spray 1.2 mg/ml: OC-01
|
Placebo (Vehicle Control) Nasal Spray
n=60 Participants
Placebo (vehicle control) nasal spray
Placebo (vehicle) nasal spray: Placebo (vehicle)
|
Total
n=113 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.3 years
STANDARD_DEVIATION 14.48 • n=99 Participants
|
61.5 years
STANDARD_DEVIATION 16.33 • n=107 Participants
|
63.3 years
STANDARD_DEVIATION 15.54 • n=206 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=99 Participants
|
47 Participants
n=107 Participants
|
88 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
44 Participants
n=99 Participants
|
45 Participants
n=107 Participants
|
89 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
47 Participants
n=99 Participants
|
50 Participants
n=107 Participants
|
97 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Corneal Fluorescein staining Score
|
2.29 units on a scale
STANDARD_DEVIATION 1.017 • n=99 Participants
|
2.17 units on a scale
STANDARD_DEVIATION 1.028 • n=107 Participants
|
2.23 units on a scale
STANDARD_DEVIATION 1.020 • n=206 Participants
|
|
Best Correct Visual Acuity (Letters)
|
75.4 Number of letters
STANDARD_DEVIATION 14.42 • n=99 Participants
|
75.9 Number of letters
STANDARD_DEVIATION 18.54 • n=107 Participants
|
75.7 Number of letters
STANDARD_DEVIATION 16.61 • n=206 Participants
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: Per Protocol Population included all subjects in the intent to treat (ITT) population that had a baseline corneal fluorescein staining score \>=2.
Corneal Fluorescein Staining was measured utilizing the Modified Oxford Grading scale. Scores range from a minimum of 0 (no staining) to a maximum of 5. A higher score indicates a worse outcome. The study eye is defined as the eye with the worst staining grade (if both eyes are eligible).
Outcome measures
| Measure |
OC-01 (Varenicline) Nasal Spray, 1.2 mg/mL
n=37 Participants
OC-01 (varenicline) nasal spray, 1.2 mg/mL
OC-01 (varenicline) nasal spray 1.2 mg/ml: OC-01
|
Placebo (Vehicle Control) Nasal Spray
n=45 Participants
Placebo (vehicle control) nasal spray
Placebo (vehicle) nasal spray: Placebo (vehicle)
|
|---|---|---|
|
Mean Change From Baseline in Corneal Fluorescein Staining
|
-0.6 score on a scale
Standard Error 0.17
|
-0.9 score on a scale
Standard Error 0.15
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: Per Protocol Population included all subjects in the intent to treat (ITT) population that had a baseline corneal fluorescein staining score \>=2.
Best Corrected Visual Acuity was assessed based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart. ETDRS letters score range from 0 to 100 letters at each assessment. A higher score in ETDRS letters indicates a better outcome. A positive change from Baseline in ETDRS letter score indicates an improvement in visual acuity.
Outcome measures
| Measure |
OC-01 (Varenicline) Nasal Spray, 1.2 mg/mL
n=37 Participants
OC-01 (varenicline) nasal spray, 1.2 mg/mL
OC-01 (varenicline) nasal spray 1.2 mg/ml: OC-01
|
Placebo (Vehicle Control) Nasal Spray
n=45 Participants
Placebo (vehicle control) nasal spray
Placebo (vehicle) nasal spray: Placebo (vehicle)
|
|---|---|---|
|
Mean Change From Baseline in Visual Acuity at Week 8
|
0.6 score on a scale
Standard Error 1.15
|
1.5 score on a scale
Standard Error 1.03
|
Adverse Events
OC-01 (Varenicline) Nasal Spray, 1.2 mg/mL
Serious events: 5 serious events
Other events: 39 other events
Deaths: 0 deaths
Placebo (Vehicle Control) Nasal Spray
Serious events: 3 serious events
Other events: 34 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
OC-01 (Varenicline) Nasal Spray, 1.2 mg/mL
n=54 participants at risk
OC-01 (varenicline) nasal spray, 1.2 mg/mL
OC-01 (varenicline) nasal spray 1.2 mg/ml: OC-01
|
Placebo (Vehicle Control) Nasal Spray
n=58 participants at risk
Placebo (vehicle control) nasal spray
Placebo (vehicle) nasal spray: Placebo (vehicle)
|
|---|---|---|
|
Gastrointestinal disorders
Large Intestinal Obstruction
|
0.00%
0/54 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
1.7%
1/58 • Number of events 1 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
|
Infections and infestations
COVID-19
|
0.00%
0/54 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
1.7%
1/58 • Number of events 1 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
|
Infections and infestations
Infective Exacerbation of bronchiectasis
|
1.9%
1/54 • Number of events 1 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
0.00%
0/58 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
|
Infections and infestations
Pyelonephritis
|
1.9%
1/54 • Number of events 1 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
0.00%
0/58 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
|
Infections and infestations
Skin Infection
|
1.9%
1/54 • Number of events 1 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
0.00%
0/58 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/54 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
1.7%
1/58 • Number of events 1 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
|
Injury, poisoning and procedural complications
Femur Fracture
|
1.9%
1/54 • Number of events 1 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
0.00%
0/58 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal Neoplasm
|
1.9%
1/54 • Number of events 1 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
0.00%
0/58 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
Other adverse events
| Measure |
OC-01 (Varenicline) Nasal Spray, 1.2 mg/mL
n=54 participants at risk
OC-01 (varenicline) nasal spray, 1.2 mg/mL
OC-01 (varenicline) nasal spray 1.2 mg/ml: OC-01
|
Placebo (Vehicle Control) Nasal Spray
n=58 participants at risk
Placebo (vehicle control) nasal spray
Placebo (vehicle) nasal spray: Placebo (vehicle)
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Nasal mucosal disorder
|
3.7%
2/54 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
8.6%
5/58 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Oedema
|
1.9%
1/54 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
1.7%
1/58 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
1.9%
1/54 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
0.00%
0/58 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
|
Congenital, familial and genetic disorders
Corneal Dystrophy
|
1.9%
1/54 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
0.00%
0/58 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
|
Eye disorders
Asthenopia
|
0.00%
0/54 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
1.7%
1/58 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
|
Eye disorders
Cataract
|
1.9%
1/54 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
0.00%
0/58 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
|
Eye disorders
Corneal Degeneration
|
1.9%
1/54 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
0.00%
0/58 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
|
Eye disorders
Conjunctivochalasis
|
0.00%
0/54 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
1.7%
1/58 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
|
Eye disorders
Corneal epithelium defect
|
7.4%
4/54 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
1.7%
1/58 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
|
Eye disorders
Corneal erosion
|
1.9%
1/54 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
0.00%
0/58 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
|
Eye disorders
Corneal neovascularisation
|
0.00%
0/54 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
1.7%
1/58 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
|
Eye disorders
Corneal Opacity
|
1.9%
1/54 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
0.00%
0/58 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
|
Eye disorders
Diplopia
|
0.00%
0/54 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
1.7%
1/58 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
|
Eye disorders
Dry Eye
|
1.9%
1/54 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
3.4%
2/58 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
|
Eye disorders
Erythema of eyelid
|
1.9%
1/54 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
0.00%
0/58 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
|
Eye disorders
Eye Discharge
|
0.00%
0/54 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
1.7%
1/58 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
|
Eye disorders
Eye Irritation
|
3.7%
2/54 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
1.7%
1/58 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
|
Eye disorders
Eye Pain
|
3.7%
2/54 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
1.7%
1/58 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
|
Eye disorders
Lacrimation Increased
|
1.9%
1/54 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
0.00%
0/58 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
|
Eye disorders
Meibomian Gland Dysfunction
|
1.9%
1/54 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
1.7%
1/58 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
|
Eye disorders
Ocular Hyperaemia
|
0.00%
0/54 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
3.4%
2/58 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
|
Eye disorders
Punctate Keratitis
|
0.00%
0/54 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
3.4%
2/58 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
|
Eye disorders
Vision Blurred
|
0.00%
0/54 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
1.7%
1/58 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
|
Eye disorders
Visual Acuity Reduced
|
0.00%
0/54 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
1.7%
1/58 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
|
Eye disorders
Vitreous Floaters
|
0.00%
0/54 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
1.7%
1/58 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
|
General disorders
Disease Progression
|
0.00%
0/54 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
1.7%
1/58 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
|
General disorders
Pain
|
0.00%
0/54 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
5.2%
3/58 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
|
General disorders
Conjunctivitis
|
0.00%
0/54 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
1.7%
1/58 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
|
General disorders
Eye Swelling
|
1.9%
1/54 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
0.00%
0/58 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
|
Gastrointestinal disorders
Abdominal Pain
|
1.9%
1/54 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
0.00%
0/58 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.9%
1/54 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
0.00%
0/58 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/54 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
1.7%
1/58 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
|
Gastrointestinal disorders
Dry Mouth
|
0.00%
0/54 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
3.4%
2/58 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/54 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
1.7%
1/58 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
|
Gastrointestinal disorders
Large Intestinal Obstruction
|
0.00%
0/54 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
1.7%
1/58 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
|
Gastrointestinal disorders
Nausea
|
3.7%
2/54 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
0.00%
0/58 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
|
Gastrointestinal disorders
Vomiting
|
1.9%
1/54 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
0.00%
0/58 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
|
General disorders
Instillation Site Exfoliation
|
0.00%
0/54 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
1.7%
1/58 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
|
General disorders
Instillation Site Irritation
|
7.4%
4/54 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
3.4%
2/58 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
|
Immune system disorders
Hypersensitivity
|
1.9%
1/54 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
0.00%
0/58 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
|
Infections and infestations
Bronchitis
|
1.9%
1/54 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
0.00%
0/58 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
|
Infections and infestations
Gastroenteritis escherichia coli
|
0.00%
0/54 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
1.7%
1/58 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
|
Infections and infestations
Gastroenteritis viral
|
1.9%
1/54 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
1.7%
1/58 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
|
Infections and infestations
Herpes Zoster
|
1.9%
1/54 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
1.7%
1/58 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/54 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
1.7%
1/58 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/54 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
1.7%
1/58 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
|
Infections and infestations
Urinary Tract Infection
|
5.6%
3/54 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
3.4%
2/58 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
1.9%
1/54 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
0.00%
0/58 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
|
Injury, poisoning and procedural complications
Ligament Sprain
|
1.9%
1/54 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
0.00%
0/58 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
|
Injury, poisoning and procedural complications
Muscle Strain
|
1.9%
1/54 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
0.00%
0/58 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
|
Investigations
Heart Rate Increased
|
0.00%
0/54 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
1.7%
1/58 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
1.9%
1/54 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
0.00%
0/58 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
1.9%
1/54 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
0.00%
0/58 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid Arthritis
|
0.00%
0/54 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
1.7%
1/58 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
|
Nervous system disorders
Carpal Tunnel Syndrome
|
0.00%
0/54 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
1.7%
1/58 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
|
Nervous system disorders
Cervical Radiculopathy
|
0.00%
0/54 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
1.7%
1/58 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
|
Nervous system disorders
Headache
|
3.7%
2/54 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
3.4%
2/58 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
|
Nervous system disorders
Migraine
|
0.00%
0/54 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
1.7%
1/58 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/54 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
1.7%
1/58 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
|
Nervous system disorders
Transient Ischaemic Attack
|
1.9%
1/54 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
0.00%
0/58 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/54 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
1.7%
1/58 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
|
Renal and urinary disorders
Hypertonic Bladder
|
1.9%
1/54 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
0.00%
0/58 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
|
Reproductive system and breast disorders
Vulvovaginal dryness
|
0.00%
0/54 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
1.7%
1/58 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.9%
1/54 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
0.00%
0/58 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/54 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
1.7%
1/58 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
3.7%
2/54 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
1.7%
1/58 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/54 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
1.7%
1/58 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
0.00%
0/54 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
1.7%
1/58 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Inflammation
|
0.00%
0/54 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
3.4%
2/58 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
1.9%
1/54 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
0.00%
0/58 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
55.6%
30/54 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
10.3%
6/58 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
|
Respiratory, thoracic and mediastinal disorders
Throat Irritation
|
11.1%
6/54 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
0.00%
0/58 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
1.9%
1/54 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
0.00%
0/58 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
|
Respiratory, thoracic and mediastinal disorders
Trichorrhexis
|
0.00%
0/54 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
1.7%
1/58 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
|
Respiratory, thoracic and mediastinal disorders
Hypertension
|
1.9%
1/54 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
0.00%
0/58 • Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place