Trial Outcomes & Findings for Safety and Efficacy of SJP-0035 Ophthalmic Solution in Patients With Moderate to Severe Corneal Epithelial Disorders (NCT NCT02929823)
NCT ID: NCT02929823
Last Updated: 2021-04-13
Results Overview
A patient will be considered a success for clearing of corneal fluorescein staining if their fluorescein staining has disappeared
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
130 participants
Primary outcome timeframe
5 weeks
Results posted on
2021-04-13
Participant Flow
Patients were recruited at study sites in the USA and were assigned to study drug only if they met all the inclusion criteria and none of the exclusion criteria. Deviations from the inclusion/exclusion criteria were not permitted.
For patients using prohibited concomitant medications within 14 days prior to planned randomization date, a 14 day washout period was required prior to first dose of study drug. Patients who failed initial screening were allowed to rescreen once.
Participant milestones
| Measure |
Placebo
Patients will administer 1 drop of 0% SJP-0035 ophthalmic solution (consisting of the vehicle for the solution) in the affected eye(s) 4 times daily for 4 weeks
Vehicle of SJP-0035 Ophthalmic solution: 0% SJP-0035 Ophthalmic Solution
|
0.0002% SJP-0035 Ophthalmic Solution
Patients will administer 1 drop of 0.0002% SJP-0035 ophthalmic solution in the affected eye(s) 4 times daily for 4 weeks.
Low Dose SJP-0035 Ophthalmic Solution: 0.0002% SJP-0035 Ophthalmic Solution
|
0.001% SJP-0035 Ophthalmic Solution
Patients will administer 1 drop of 0.001% SJP-0035 ophthalmic solution in the affected eye(s) 4 times daily for 4 weeks.
High Dose SJP-0035 Ophthalmic Solution: 0.001% SJP-0035 Ophthalmic Solution
|
|---|---|---|---|
|
Overall Study
STARTED
|
42
|
46
|
42
|
|
Overall Study
COMPLETED
|
39
|
40
|
38
|
|
Overall Study
NOT COMPLETED
|
3
|
6
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Efficacy of SJP-0035 Ophthalmic Solution in Patients With Moderate to Severe Corneal Epithelial Disorders
Baseline characteristics by cohort
| Measure |
Placebo
n=42 Participants
Patients will administer 1 drop of 0% SJP-0035 ophthalmic solution (consisting of the vehicle for the solution) in the affected eye(s) 4 times daily for 4 weeks
Vehicle of SJP-0035 Ophthalmic solution: 0% SJP-0035 Ophthalmic Solution
|
0.0002% SJP-0035 Ophthalmic Solution
n=46 Participants
Patients will administer 1 drop of 0.0002% SJP-0035 ophthalmic solution in the affected eye(s) 4 times daily for 4 weeks.
Low Dose SJP-0035 Ophthalmic Solution: 0.0002% SJP-0035 Ophthalmic Solution
|
0.001% SJP-0035 Ophthalmic Solution
n=42 Participants
Patients will administer 1 drop of 0.001% SJP-0035 ophthalmic solution in the affected eye(s) 4 times daily for 4 weeks.
High Dose SJP-0035 Ophthalmic Solution: 0.001% SJP-0035 Ophthalmic Solution
|
Total
n=130 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
7 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
28 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
35 Participants
n=99 Participants
|
34 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
102 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
42 Participants
n=99 Participants
|
46 Participants
n=107 Participants
|
42 Participants
n=206 Participants
|
130 Participants
n=7 Participants
|
|
Age, Continuous
|
62.5 years
STANDARD_DEVIATION 10.22 • n=99 Participants
|
61.7 years
STANDARD_DEVIATION 9.13 • n=107 Participants
|
60.7 years
STANDARD_DEVIATION 11.91 • n=206 Participants
|
61.6 years
STANDARD_DEVIATION 10.39 • n=7 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
23 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=99 Participants
|
39 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
107 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
White
|
35 Participants
n=99 Participants
|
43 Participants
n=107 Participants
|
37 Participants
n=206 Participants
|
115 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 5 weeksPopulation: Full Analysis Set: All patients randomly assigned to receive double-masked study drug, who received at least 1 dose of study drug in the study eye, and who had at least 1 post-baseline assessment for the primary efficacy endpoint.
A patient will be considered a success for clearing of corneal fluorescein staining if their fluorescein staining has disappeared
Outcome measures
| Measure |
Placebo
n=42 Participants
Patients will administer 1 drop of 0% SJP-0035 ophthalmic solution (consisting of the vehicle for the solution) in the affected eye(s) 4 times daily for 4 weeks
Vehicle of SJP-0035 Ophthalmic solution: 0% SJP-0035 Ophthalmic Solution
|
0.0002% SJP-0035 Ophthalmic Solution
n=45 Participants
Patients will administer 1 drop of 0.0002% SJP-0035 ophthalmic solution in the affected eye(s) 4 times daily for 4 weeks.
Low Dose SJP-0035 Ophthalmic Solution: 0.0002% SJP-0035 Ophthalmic Solution
|
0.001% SJP-0035 Ophthalmic Solution
n=42 Participants
Patients will administer 1 drop of 0.001% SJP-0035 ophthalmic solution in the affected eye(s) 4 times daily for 4 weeks.
High Dose SJP-0035 Ophthalmic Solution: 0.001% SJP-0035 Ophthalmic Solution
|
|---|---|---|---|
|
Number of Participants With Clearing of Corneal Fluorescein Staining at Week 5 at Week 5
|
5 Participants
|
7 Participants
|
12 Participants
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
0.0002% SJP-0035 Ophthalmic Solution
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
0.001% SJP-0035 Ophthalmic Solution
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=42 participants at risk
Patients will administer 1 drop of 0% SJP-0035 ophthalmic solution (consisting of the vehicle for the solution) in the affected eye(s) 4 times daily for 4 weeks
Vehicle of SJP-0035 Ophthalmic solution: 0% SJP-0035 Ophthalmic Solution
|
0.0002% SJP-0035 Ophthalmic Solution
n=46 participants at risk
Patients will administer 1 drop of 0.0002% SJP-0035 ophthalmic solution in the affected eye(s) 4 times daily for 4 weeks.
Low Dose SJP-0035 Ophthalmic Solution: 0.0002% SJP-0035 Ophthalmic Solution
|
0.001% SJP-0035 Ophthalmic Solution
n=42 participants at risk
Patients will administer 1 drop of 0.001% SJP-0035 ophthalmic solution in the affected eye(s) 4 times daily for 4 weeks.
High Dose SJP-0035 Ophthalmic Solution: 0.001% SJP-0035 Ophthalmic Solution
|
|---|---|---|---|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/42 • Up to 30 days following final dose (Week 5)
A Treatment-Emergent Adverse Event (TEAE) is defined as any event not present before exposure to study drug, or any event already present that worsens in either intensity or frequency after exposure to study drug.
|
0.00%
0/46 • Up to 30 days following final dose (Week 5)
A Treatment-Emergent Adverse Event (TEAE) is defined as any event not present before exposure to study drug, or any event already present that worsens in either intensity or frequency after exposure to study drug.
|
2.4%
1/42 • Number of events 1 • Up to 30 days following final dose (Week 5)
A Treatment-Emergent Adverse Event (TEAE) is defined as any event not present before exposure to study drug, or any event already present that worsens in either intensity or frequency after exposure to study drug.
|
Other adverse events
| Measure |
Placebo
n=42 participants at risk
Patients will administer 1 drop of 0% SJP-0035 ophthalmic solution (consisting of the vehicle for the solution) in the affected eye(s) 4 times daily for 4 weeks
Vehicle of SJP-0035 Ophthalmic solution: 0% SJP-0035 Ophthalmic Solution
|
0.0002% SJP-0035 Ophthalmic Solution
n=46 participants at risk
Patients will administer 1 drop of 0.0002% SJP-0035 ophthalmic solution in the affected eye(s) 4 times daily for 4 weeks.
Low Dose SJP-0035 Ophthalmic Solution: 0.0002% SJP-0035 Ophthalmic Solution
|
0.001% SJP-0035 Ophthalmic Solution
n=42 participants at risk
Patients will administer 1 drop of 0.001% SJP-0035 ophthalmic solution in the affected eye(s) 4 times daily for 4 weeks.
High Dose SJP-0035 Ophthalmic Solution: 0.001% SJP-0035 Ophthalmic Solution
|
|---|---|---|---|
|
Infections and infestations
Upper Respiratory Tract Infection
|
2.4%
1/42 • Number of events 1 • Up to 30 days following final dose (Week 5)
A Treatment-Emergent Adverse Event (TEAE) is defined as any event not present before exposure to study drug, or any event already present that worsens in either intensity or frequency after exposure to study drug.
|
2.2%
1/46 • Number of events 1 • Up to 30 days following final dose (Week 5)
A Treatment-Emergent Adverse Event (TEAE) is defined as any event not present before exposure to study drug, or any event already present that worsens in either intensity or frequency after exposure to study drug.
|
0.00%
0/42 • Up to 30 days following final dose (Week 5)
A Treatment-Emergent Adverse Event (TEAE) is defined as any event not present before exposure to study drug, or any event already present that worsens in either intensity or frequency after exposure to study drug.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
2.4%
1/42 • Number of events 1 • Up to 30 days following final dose (Week 5)
A Treatment-Emergent Adverse Event (TEAE) is defined as any event not present before exposure to study drug, or any event already present that worsens in either intensity or frequency after exposure to study drug.
|
0.00%
0/46 • Up to 30 days following final dose (Week 5)
A Treatment-Emergent Adverse Event (TEAE) is defined as any event not present before exposure to study drug, or any event already present that worsens in either intensity or frequency after exposure to study drug.
|
0.00%
0/42 • Up to 30 days following final dose (Week 5)
A Treatment-Emergent Adverse Event (TEAE) is defined as any event not present before exposure to study drug, or any event already present that worsens in either intensity or frequency after exposure to study drug.
|
|
Eye disorders
Conjunctival Hyperaemia
|
4.8%
2/42 • Number of events 4 • Up to 30 days following final dose (Week 5)
A Treatment-Emergent Adverse Event (TEAE) is defined as any event not present before exposure to study drug, or any event already present that worsens in either intensity or frequency after exposure to study drug.
|
4.3%
2/46 • Number of events 4 • Up to 30 days following final dose (Week 5)
A Treatment-Emergent Adverse Event (TEAE) is defined as any event not present before exposure to study drug, or any event already present that worsens in either intensity or frequency after exposure to study drug.
|
4.8%
2/42 • Number of events 4 • Up to 30 days following final dose (Week 5)
A Treatment-Emergent Adverse Event (TEAE) is defined as any event not present before exposure to study drug, or any event already present that worsens in either intensity or frequency after exposure to study drug.
|
|
Infections and infestations
Sinusitis
|
2.4%
1/42 • Number of events 1 • Up to 30 days following final dose (Week 5)
A Treatment-Emergent Adverse Event (TEAE) is defined as any event not present before exposure to study drug, or any event already present that worsens in either intensity or frequency after exposure to study drug.
|
2.2%
1/46 • Number of events 1 • Up to 30 days following final dose (Week 5)
A Treatment-Emergent Adverse Event (TEAE) is defined as any event not present before exposure to study drug, or any event already present that worsens in either intensity or frequency after exposure to study drug.
|
2.4%
1/42 • Number of events 1 • Up to 30 days following final dose (Week 5)
A Treatment-Emergent Adverse Event (TEAE) is defined as any event not present before exposure to study drug, or any event already present that worsens in either intensity or frequency after exposure to study drug.
|
|
Eye disorders
Photophobia
|
4.8%
2/42 • Number of events 2 • Up to 30 days following final dose (Week 5)
A Treatment-Emergent Adverse Event (TEAE) is defined as any event not present before exposure to study drug, or any event already present that worsens in either intensity or frequency after exposure to study drug.
|
0.00%
0/46 • Up to 30 days following final dose (Week 5)
A Treatment-Emergent Adverse Event (TEAE) is defined as any event not present before exposure to study drug, or any event already present that worsens in either intensity or frequency after exposure to study drug.
|
0.00%
0/42 • Up to 30 days following final dose (Week 5)
A Treatment-Emergent Adverse Event (TEAE) is defined as any event not present before exposure to study drug, or any event already present that worsens in either intensity or frequency after exposure to study drug.
|
|
Injury, poisoning and procedural complications
Retinal Injury
|
2.4%
1/42 • Number of events 1 • Up to 30 days following final dose (Week 5)
A Treatment-Emergent Adverse Event (TEAE) is defined as any event not present before exposure to study drug, or any event already present that worsens in either intensity or frequency after exposure to study drug.
|
0.00%
0/46 • Up to 30 days following final dose (Week 5)
A Treatment-Emergent Adverse Event (TEAE) is defined as any event not present before exposure to study drug, or any event already present that worsens in either intensity or frequency after exposure to study drug.
|
0.00%
0/42 • Up to 30 days following final dose (Week 5)
A Treatment-Emergent Adverse Event (TEAE) is defined as any event not present before exposure to study drug, or any event already present that worsens in either intensity or frequency after exposure to study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Blepharal Papilloma
|
2.4%
1/42 • Number of events 1 • Up to 30 days following final dose (Week 5)
A Treatment-Emergent Adverse Event (TEAE) is defined as any event not present before exposure to study drug, or any event already present that worsens in either intensity or frequency after exposure to study drug.
|
0.00%
0/46 • Up to 30 days following final dose (Week 5)
A Treatment-Emergent Adverse Event (TEAE) is defined as any event not present before exposure to study drug, or any event already present that worsens in either intensity or frequency after exposure to study drug.
|
0.00%
0/42 • Up to 30 days following final dose (Week 5)
A Treatment-Emergent Adverse Event (TEAE) is defined as any event not present before exposure to study drug, or any event already present that worsens in either intensity or frequency after exposure to study drug.
|
|
Eye disorders
Eye Irritation
|
2.4%
1/42 • Number of events 2 • Up to 30 days following final dose (Week 5)
A Treatment-Emergent Adverse Event (TEAE) is defined as any event not present before exposure to study drug, or any event already present that worsens in either intensity or frequency after exposure to study drug.
|
0.00%
0/46 • Up to 30 days following final dose (Week 5)
A Treatment-Emergent Adverse Event (TEAE) is defined as any event not present before exposure to study drug, or any event already present that worsens in either intensity or frequency after exposure to study drug.
|
2.4%
1/42 • Number of events 2 • Up to 30 days following final dose (Week 5)
A Treatment-Emergent Adverse Event (TEAE) is defined as any event not present before exposure to study drug, or any event already present that worsens in either intensity or frequency after exposure to study drug.
|
|
Eye disorders
Eye Pain
|
2.4%
1/42 • Number of events 1 • Up to 30 days following final dose (Week 5)
A Treatment-Emergent Adverse Event (TEAE) is defined as any event not present before exposure to study drug, or any event already present that worsens in either intensity or frequency after exposure to study drug.
|
0.00%
0/46 • Up to 30 days following final dose (Week 5)
A Treatment-Emergent Adverse Event (TEAE) is defined as any event not present before exposure to study drug, or any event already present that worsens in either intensity or frequency after exposure to study drug.
|
2.4%
1/42 • Number of events 2 • Up to 30 days following final dose (Week 5)
A Treatment-Emergent Adverse Event (TEAE) is defined as any event not present before exposure to study drug, or any event already present that worsens in either intensity or frequency after exposure to study drug.
|
|
Infections and infestations
Viral Pharyngitis
|
0.00%
0/42 • Up to 30 days following final dose (Week 5)
A Treatment-Emergent Adverse Event (TEAE) is defined as any event not present before exposure to study drug, or any event already present that worsens in either intensity or frequency after exposure to study drug.
|
2.2%
1/46 • Number of events 1 • Up to 30 days following final dose (Week 5)
A Treatment-Emergent Adverse Event (TEAE) is defined as any event not present before exposure to study drug, or any event already present that worsens in either intensity or frequency after exposure to study drug.
|
0.00%
0/42 • Up to 30 days following final dose (Week 5)
A Treatment-Emergent Adverse Event (TEAE) is defined as any event not present before exposure to study drug, or any event already present that worsens in either intensity or frequency after exposure to study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Congestion
|
0.00%
0/42 • Up to 30 days following final dose (Week 5)
A Treatment-Emergent Adverse Event (TEAE) is defined as any event not present before exposure to study drug, or any event already present that worsens in either intensity or frequency after exposure to study drug.
|
2.2%
1/46 • Number of events 1 • Up to 30 days following final dose (Week 5)
A Treatment-Emergent Adverse Event (TEAE) is defined as any event not present before exposure to study drug, or any event already present that worsens in either intensity or frequency after exposure to study drug.
|
0.00%
0/42 • Up to 30 days following final dose (Week 5)
A Treatment-Emergent Adverse Event (TEAE) is defined as any event not present before exposure to study drug, or any event already present that worsens in either intensity or frequency after exposure to study drug.
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/42 • Up to 30 days following final dose (Week 5)
A Treatment-Emergent Adverse Event (TEAE) is defined as any event not present before exposure to study drug, or any event already present that worsens in either intensity or frequency after exposure to study drug.
|
4.3%
2/46 • Number of events 2 • Up to 30 days following final dose (Week 5)
A Treatment-Emergent Adverse Event (TEAE) is defined as any event not present before exposure to study drug, or any event already present that worsens in either intensity or frequency after exposure to study drug.
|
2.4%
1/42 • Number of events 1 • Up to 30 days following final dose (Week 5)
A Treatment-Emergent Adverse Event (TEAE) is defined as any event not present before exposure to study drug, or any event already present that worsens in either intensity or frequency after exposure to study drug.
|
|
Eye disorders
Eye Pruritus
|
0.00%
0/42 • Up to 30 days following final dose (Week 5)
A Treatment-Emergent Adverse Event (TEAE) is defined as any event not present before exposure to study drug, or any event already present that worsens in either intensity or frequency after exposure to study drug.
|
2.2%
1/46 • Number of events 2 • Up to 30 days following final dose (Week 5)
A Treatment-Emergent Adverse Event (TEAE) is defined as any event not present before exposure to study drug, or any event already present that worsens in either intensity or frequency after exposure to study drug.
|
0.00%
0/42 • Up to 30 days following final dose (Week 5)
A Treatment-Emergent Adverse Event (TEAE) is defined as any event not present before exposure to study drug, or any event already present that worsens in either intensity or frequency after exposure to study drug.
|
|
Eye disorders
Erythema of Eyelid
|
0.00%
0/42 • Up to 30 days following final dose (Week 5)
A Treatment-Emergent Adverse Event (TEAE) is defined as any event not present before exposure to study drug, or any event already present that worsens in either intensity or frequency after exposure to study drug.
|
2.2%
1/46 • Number of events 2 • Up to 30 days following final dose (Week 5)
A Treatment-Emergent Adverse Event (TEAE) is defined as any event not present before exposure to study drug, or any event already present that worsens in either intensity or frequency after exposure to study drug.
|
2.4%
1/42 • Number of events 2 • Up to 30 days following final dose (Week 5)
A Treatment-Emergent Adverse Event (TEAE) is defined as any event not present before exposure to study drug, or any event already present that worsens in either intensity or frequency after exposure to study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
0.00%
0/42 • Up to 30 days following final dose (Week 5)
A Treatment-Emergent Adverse Event (TEAE) is defined as any event not present before exposure to study drug, or any event already present that worsens in either intensity or frequency after exposure to study drug.
|
2.2%
1/46 • Number of events 1 • Up to 30 days following final dose (Week 5)
A Treatment-Emergent Adverse Event (TEAE) is defined as any event not present before exposure to study drug, or any event already present that worsens in either intensity or frequency after exposure to study drug.
|
0.00%
0/42 • Up to 30 days following final dose (Week 5)
A Treatment-Emergent Adverse Event (TEAE) is defined as any event not present before exposure to study drug, or any event already present that worsens in either intensity or frequency after exposure to study drug.
|
|
Eye disorders
Vitreous Floaters
|
0.00%
0/42 • Up to 30 days following final dose (Week 5)
A Treatment-Emergent Adverse Event (TEAE) is defined as any event not present before exposure to study drug, or any event already present that worsens in either intensity or frequency after exposure to study drug.
|
2.2%
1/46 • Number of events 1 • Up to 30 days following final dose (Week 5)
A Treatment-Emergent Adverse Event (TEAE) is defined as any event not present before exposure to study drug, or any event already present that worsens in either intensity or frequency after exposure to study drug.
|
0.00%
0/42 • Up to 30 days following final dose (Week 5)
A Treatment-Emergent Adverse Event (TEAE) is defined as any event not present before exposure to study drug, or any event already present that worsens in either intensity or frequency after exposure to study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/42 • Up to 30 days following final dose (Week 5)
A Treatment-Emergent Adverse Event (TEAE) is defined as any event not present before exposure to study drug, or any event already present that worsens in either intensity or frequency after exposure to study drug.
|
4.3%
2/46 • Number of events 2 • Up to 30 days following final dose (Week 5)
A Treatment-Emergent Adverse Event (TEAE) is defined as any event not present before exposure to study drug, or any event already present that worsens in either intensity or frequency after exposure to study drug.
|
2.4%
1/42 • Number of events 1 • Up to 30 days following final dose (Week 5)
A Treatment-Emergent Adverse Event (TEAE) is defined as any event not present before exposure to study drug, or any event already present that worsens in either intensity or frequency after exposure to study drug.
|
|
Nervous system disorders
Headache
|
0.00%
0/42 • Up to 30 days following final dose (Week 5)
A Treatment-Emergent Adverse Event (TEAE) is defined as any event not present before exposure to study drug, or any event already present that worsens in either intensity or frequency after exposure to study drug.
|
2.2%
1/46 • Number of events 1 • Up to 30 days following final dose (Week 5)
A Treatment-Emergent Adverse Event (TEAE) is defined as any event not present before exposure to study drug, or any event already present that worsens in either intensity or frequency after exposure to study drug.
|
0.00%
0/42 • Up to 30 days following final dose (Week 5)
A Treatment-Emergent Adverse Event (TEAE) is defined as any event not present before exposure to study drug, or any event already present that worsens in either intensity or frequency after exposure to study drug.
|
|
Eye disorders
Lacrimation Increased
|
0.00%
0/42 • Up to 30 days following final dose (Week 5)
A Treatment-Emergent Adverse Event (TEAE) is defined as any event not present before exposure to study drug, or any event already present that worsens in either intensity or frequency after exposure to study drug.
|
2.2%
1/46 • Number of events 1 • Up to 30 days following final dose (Week 5)
A Treatment-Emergent Adverse Event (TEAE) is defined as any event not present before exposure to study drug, or any event already present that worsens in either intensity or frequency after exposure to study drug.
|
0.00%
0/42 • Up to 30 days following final dose (Week 5)
A Treatment-Emergent Adverse Event (TEAE) is defined as any event not present before exposure to study drug, or any event already present that worsens in either intensity or frequency after exposure to study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/42 • Up to 30 days following final dose (Week 5)
A Treatment-Emergent Adverse Event (TEAE) is defined as any event not present before exposure to study drug, or any event already present that worsens in either intensity or frequency after exposure to study drug.
|
2.2%
1/46 • Number of events 1 • Up to 30 days following final dose (Week 5)
A Treatment-Emergent Adverse Event (TEAE) is defined as any event not present before exposure to study drug, or any event already present that worsens in either intensity or frequency after exposure to study drug.
|
0.00%
0/42 • Up to 30 days following final dose (Week 5)
A Treatment-Emergent Adverse Event (TEAE) is defined as any event not present before exposure to study drug, or any event already present that worsens in either intensity or frequency after exposure to study drug.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/42 • Up to 30 days following final dose (Week 5)
A Treatment-Emergent Adverse Event (TEAE) is defined as any event not present before exposure to study drug, or any event already present that worsens in either intensity or frequency after exposure to study drug.
|
2.2%
1/46 • Number of events 1 • Up to 30 days following final dose (Week 5)
A Treatment-Emergent Adverse Event (TEAE) is defined as any event not present before exposure to study drug, or any event already present that worsens in either intensity or frequency after exposure to study drug.
|
0.00%
0/42 • Up to 30 days following final dose (Week 5)
A Treatment-Emergent Adverse Event (TEAE) is defined as any event not present before exposure to study drug, or any event already present that worsens in either intensity or frequency after exposure to study drug.
|
|
Investigations
Weight Decreased
|
0.00%
0/42 • Up to 30 days following final dose (Week 5)
A Treatment-Emergent Adverse Event (TEAE) is defined as any event not present before exposure to study drug, or any event already present that worsens in either intensity or frequency after exposure to study drug.
|
2.2%
1/46 • Number of events 1 • Up to 30 days following final dose (Week 5)
A Treatment-Emergent Adverse Event (TEAE) is defined as any event not present before exposure to study drug, or any event already present that worsens in either intensity or frequency after exposure to study drug.
|
0.00%
0/42 • Up to 30 days following final dose (Week 5)
A Treatment-Emergent Adverse Event (TEAE) is defined as any event not present before exposure to study drug, or any event already present that worsens in either intensity or frequency after exposure to study drug.
|
|
Skin and subcutaneous tissue disorders
Decubitus Ulcer
|
0.00%
0/42 • Up to 30 days following final dose (Week 5)
A Treatment-Emergent Adverse Event (TEAE) is defined as any event not present before exposure to study drug, or any event already present that worsens in either intensity or frequency after exposure to study drug.
|
2.2%
1/46 • Number of events 1 • Up to 30 days following final dose (Week 5)
A Treatment-Emergent Adverse Event (TEAE) is defined as any event not present before exposure to study drug, or any event already present that worsens in either intensity or frequency after exposure to study drug.
|
0.00%
0/42 • Up to 30 days following final dose (Week 5)
A Treatment-Emergent Adverse Event (TEAE) is defined as any event not present before exposure to study drug, or any event already present that worsens in either intensity or frequency after exposure to study drug.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/42 • Up to 30 days following final dose (Week 5)
A Treatment-Emergent Adverse Event (TEAE) is defined as any event not present before exposure to study drug, or any event already present that worsens in either intensity or frequency after exposure to study drug.
|
2.2%
1/46 • Number of events 1 • Up to 30 days following final dose (Week 5)
A Treatment-Emergent Adverse Event (TEAE) is defined as any event not present before exposure to study drug, or any event already present that worsens in either intensity or frequency after exposure to study drug.
|
0.00%
0/42 • Up to 30 days following final dose (Week 5)
A Treatment-Emergent Adverse Event (TEAE) is defined as any event not present before exposure to study drug, or any event already present that worsens in either intensity or frequency after exposure to study drug.
|
|
Infections and infestations
Influenza
|
0.00%
0/42 • Up to 30 days following final dose (Week 5)
A Treatment-Emergent Adverse Event (TEAE) is defined as any event not present before exposure to study drug, or any event already present that worsens in either intensity or frequency after exposure to study drug.
|
2.2%
1/46 • Number of events 1 • Up to 30 days following final dose (Week 5)
A Treatment-Emergent Adverse Event (TEAE) is defined as any event not present before exposure to study drug, or any event already present that worsens in either intensity or frequency after exposure to study drug.
|
0.00%
0/42 • Up to 30 days following final dose (Week 5)
A Treatment-Emergent Adverse Event (TEAE) is defined as any event not present before exposure to study drug, or any event already present that worsens in either intensity or frequency after exposure to study drug.
|
|
Eye disorders
Foreign Body Sensation in Eyes
|
0.00%
0/42 • Up to 30 days following final dose (Week 5)
A Treatment-Emergent Adverse Event (TEAE) is defined as any event not present before exposure to study drug, or any event already present that worsens in either intensity or frequency after exposure to study drug.
|
0.00%
0/46 • Up to 30 days following final dose (Week 5)
A Treatment-Emergent Adverse Event (TEAE) is defined as any event not present before exposure to study drug, or any event already present that worsens in either intensity or frequency after exposure to study drug.
|
2.4%
1/42 • Number of events 2 • Up to 30 days following final dose (Week 5)
A Treatment-Emergent Adverse Event (TEAE) is defined as any event not present before exposure to study drug, or any event already present that worsens in either intensity or frequency after exposure to study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Viral Upper Respiratory Tract Infection
|
0.00%
0/42 • Up to 30 days following final dose (Week 5)
A Treatment-Emergent Adverse Event (TEAE) is defined as any event not present before exposure to study drug, or any event already present that worsens in either intensity or frequency after exposure to study drug.
|
0.00%
0/46 • Up to 30 days following final dose (Week 5)
A Treatment-Emergent Adverse Event (TEAE) is defined as any event not present before exposure to study drug, or any event already present that worsens in either intensity or frequency after exposure to study drug.
|
2.4%
1/42 • Number of events 1 • Up to 30 days following final dose (Week 5)
A Treatment-Emergent Adverse Event (TEAE) is defined as any event not present before exposure to study drug, or any event already present that worsens in either intensity or frequency after exposure to study drug.
|
|
Eye disorders
Pinguecula
|
0.00%
0/42 • Up to 30 days following final dose (Week 5)
A Treatment-Emergent Adverse Event (TEAE) is defined as any event not present before exposure to study drug, or any event already present that worsens in either intensity or frequency after exposure to study drug.
|
0.00%
0/46 • Up to 30 days following final dose (Week 5)
A Treatment-Emergent Adverse Event (TEAE) is defined as any event not present before exposure to study drug, or any event already present that worsens in either intensity or frequency after exposure to study drug.
|
2.4%
1/42 • Number of events 1 • Up to 30 days following final dose (Week 5)
A Treatment-Emergent Adverse Event (TEAE) is defined as any event not present before exposure to study drug, or any event already present that worsens in either intensity or frequency after exposure to study drug.
|
|
Infections and infestations
Conjunctivitis Viral
|
0.00%
0/42 • Up to 30 days following final dose (Week 5)
A Treatment-Emergent Adverse Event (TEAE) is defined as any event not present before exposure to study drug, or any event already present that worsens in either intensity or frequency after exposure to study drug.
|
0.00%
0/46 • Up to 30 days following final dose (Week 5)
A Treatment-Emergent Adverse Event (TEAE) is defined as any event not present before exposure to study drug, or any event already present that worsens in either intensity or frequency after exposure to study drug.
|
2.4%
1/42 • Number of events 1 • Up to 30 days following final dose (Week 5)
A Treatment-Emergent Adverse Event (TEAE) is defined as any event not present before exposure to study drug, or any event already present that worsens in either intensity or frequency after exposure to study drug.
|
|
Eye disorders
Trichiasis
|
0.00%
0/42 • Up to 30 days following final dose (Week 5)
A Treatment-Emergent Adverse Event (TEAE) is defined as any event not present before exposure to study drug, or any event already present that worsens in either intensity or frequency after exposure to study drug.
|
0.00%
0/46 • Up to 30 days following final dose (Week 5)
A Treatment-Emergent Adverse Event (TEAE) is defined as any event not present before exposure to study drug, or any event already present that worsens in either intensity or frequency after exposure to study drug.
|
2.4%
1/42 • Number of events 1 • Up to 30 days following final dose (Week 5)
A Treatment-Emergent Adverse Event (TEAE) is defined as any event not present before exposure to study drug, or any event already present that worsens in either intensity or frequency after exposure to study drug.
|
|
Eye disorders
Conjunctival Disorder
|
0.00%
0/42 • Up to 30 days following final dose (Week 5)
A Treatment-Emergent Adverse Event (TEAE) is defined as any event not present before exposure to study drug, or any event already present that worsens in either intensity or frequency after exposure to study drug.
|
0.00%
0/46 • Up to 30 days following final dose (Week 5)
A Treatment-Emergent Adverse Event (TEAE) is defined as any event not present before exposure to study drug, or any event already present that worsens in either intensity or frequency after exposure to study drug.
|
2.4%
1/42 • Number of events 2 • Up to 30 days following final dose (Week 5)
A Treatment-Emergent Adverse Event (TEAE) is defined as any event not present before exposure to study drug, or any event already present that worsens in either intensity or frequency after exposure to study drug.
|
|
Investigations
Blood Creatine Phosphokinase
|
0.00%
0/42 • Up to 30 days following final dose (Week 5)
A Treatment-Emergent Adverse Event (TEAE) is defined as any event not present before exposure to study drug, or any event already present that worsens in either intensity or frequency after exposure to study drug.
|
0.00%
0/46 • Up to 30 days following final dose (Week 5)
A Treatment-Emergent Adverse Event (TEAE) is defined as any event not present before exposure to study drug, or any event already present that worsens in either intensity or frequency after exposure to study drug.
|
2.4%
1/42 • Number of events 1 • Up to 30 days following final dose (Week 5)
A Treatment-Emergent Adverse Event (TEAE) is defined as any event not present before exposure to study drug, or any event already present that worsens in either intensity or frequency after exposure to study drug.
|
|
Eye disorders
Glare
|
0.00%
0/42 • Up to 30 days following final dose (Week 5)
A Treatment-Emergent Adverse Event (TEAE) is defined as any event not present before exposure to study drug, or any event already present that worsens in either intensity or frequency after exposure to study drug.
|
0.00%
0/46 • Up to 30 days following final dose (Week 5)
A Treatment-Emergent Adverse Event (TEAE) is defined as any event not present before exposure to study drug, or any event already present that worsens in either intensity or frequency after exposure to study drug.
|
2.4%
1/42 • Number of events 4 • Up to 30 days following final dose (Week 5)
A Treatment-Emergent Adverse Event (TEAE) is defined as any event not present before exposure to study drug, or any event already present that worsens in either intensity or frequency after exposure to study drug.
|
|
Eye disorders
Eye Discharge
|
0.00%
0/42 • Up to 30 days following final dose (Week 5)
A Treatment-Emergent Adverse Event (TEAE) is defined as any event not present before exposure to study drug, or any event already present that worsens in either intensity or frequency after exposure to study drug.
|
0.00%
0/46 • Up to 30 days following final dose (Week 5)
A Treatment-Emergent Adverse Event (TEAE) is defined as any event not present before exposure to study drug, or any event already present that worsens in either intensity or frequency after exposure to study drug.
|
2.4%
1/42 • Number of events 2 • Up to 30 days following final dose (Week 5)
A Treatment-Emergent Adverse Event (TEAE) is defined as any event not present before exposure to study drug, or any event already present that worsens in either intensity or frequency after exposure to study drug.
|
|
Eye disorders
Vision Blurred
|
0.00%
0/42 • Up to 30 days following final dose (Week 5)
A Treatment-Emergent Adverse Event (TEAE) is defined as any event not present before exposure to study drug, or any event already present that worsens in either intensity or frequency after exposure to study drug.
|
0.00%
0/46 • Up to 30 days following final dose (Week 5)
A Treatment-Emergent Adverse Event (TEAE) is defined as any event not present before exposure to study drug, or any event already present that worsens in either intensity or frequency after exposure to study drug.
|
2.4%
1/42 • Number of events 2 • Up to 30 days following final dose (Week 5)
A Treatment-Emergent Adverse Event (TEAE) is defined as any event not present before exposure to study drug, or any event already present that worsens in either intensity or frequency after exposure to study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Principal Investigator will not disclose information regarding this clinical investigation, or publish results of the investigation without authorization from Senju Pharmaceuticals Co., Ltd.
- Publication restrictions are in place
Restriction type: OTHER