Trial Outcomes & Findings for Safety and Efficacy of Brimonidine Tartrate Posterior Segment Drug Delivery System in Improving Visual Function (NCT NCT00972374)
NCT ID: NCT00972374
Last Updated: 2013-04-24
Results Overview
BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly indicates that vision has improved. The percentage of patients with at least a 15-letter increase in BCVA in the study eye is reported.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
44 participants
Primary outcome timeframe
Month 3
Results posted on
2013-04-24
Participant Flow
Participant milestones
| Measure |
400 ug Brimonidine Implant
400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye.
|
200 ug Brimonidine Implant
200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye.
|
Sham (no Implant)
Sham Posterior Segment Drug Delivery system on Day 1 in the study eye.
|
|---|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
14
|
|
Overall Study
COMPLETED
|
13
|
15
|
13
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Efficacy of Brimonidine Tartrate Posterior Segment Drug Delivery System in Improving Visual Function
Baseline characteristics by cohort
| Measure |
400 ug Brimonidine Implant
n=15 Participants
400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye.
|
200 ug Brimonidine Implant
n=15 Participants
200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye.
|
Sham (no Implant)
n=14 Participants
Sham Posterior Segment Drug Delivery system on Day 1 in the study eye.
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Continuous
|
54.2 Years
STANDARD_DEVIATION 17.12 • n=99 Participants
|
54.3 Years
STANDARD_DEVIATION 20.36 • n=107 Participants
|
56.1 Years
STANDARD_DEVIATION 15.19 • n=206 Participants
|
54.9 Years
STANDARD_DEVIATION 17.35 • n=7 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
16 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
28 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Month 3Population: Intent to Treat: all randomized patients
BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly indicates that vision has improved. The percentage of patients with at least a 15-letter increase in BCVA in the study eye is reported.
Outcome measures
| Measure |
400 ug Brimonidine Implant
n=15 Participants
400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye.
|
200 ug Brimonidine Implant
n=15 Participants
200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye.
|
Sham (no Implant)
n=14 Participants
Sham Posterior Segment Drug Delivery system on Day 1 in the study eye.
|
|---|---|---|---|
|
Percentage of Patients With at Least a 15-Letter Increase From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye
|
6.7 Percentage of Patients
|
6.7 Percentage of Patients
|
0 Percentage of Patients
|
SECONDARY outcome
Timeframe: Baseline, Month 3Population: Intent to Treat: all randomized patients
BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening.
Outcome measures
| Measure |
400 ug Brimonidine Implant
n=15 Participants
400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye.
|
200 ug Brimonidine Implant
n=15 Participants
200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye.
|
Sham (no Implant)
n=14 Participants
Sham Posterior Segment Drug Delivery system on Day 1 in the study eye.
|
|---|---|---|---|
|
Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye
Baseline
|
46.6 Number of Letters Read Correctly
Standard Deviation 13.69
|
53.3 Number of Letters Read Correctly
Standard Deviation 8.46
|
50.3 Number of Letters Read Correctly
Standard Deviation 10.92
|
|
Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye
Change from Baseline at Month 3
|
6.0 Number of Letters Read Correctly
Standard Deviation 6.23
|
3.1 Number of Letters Read Correctly
Standard Deviation 6.78
|
4.8 Number of Letters Read Correctly
Standard Deviation 4.64
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 MonthsPopulation: Intent to Treat: all randomized patients
IOP is the fluid pressure inside the eye. The percentage of patients with IOP \< 10 millimeters of mercury (mmHg) in the study eye at any follow up visit is presented.
Outcome measures
| Measure |
400 ug Brimonidine Implant
n=15 Participants
400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye.
|
200 ug Brimonidine Implant
n=15 Participants
200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye.
|
Sham (no Implant)
n=14 Participants
Sham Posterior Segment Drug Delivery system on Day 1 in the study eye.
|
|---|---|---|---|
|
Percentage of Patients With Intraocular Pressure (IOP) < 10 mmHg in the Study Eye at Any Follow up Visit
|
20.0 Percentage of Patients
|
26.7 Percentage of Patients
|
28.6 Percentage of Patients
|
Adverse Events
400 ug Brimonidine Implant
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
200 ug Brimonidine Implant
Serious events: 2 serious events
Other events: 12 other events
Deaths: 0 deaths
Sham (no Implant)
Serious events: 2 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
400 ug Brimonidine Implant
n=15 participants at risk
400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye.
|
200 ug Brimonidine Implant
n=15 participants at risk
200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye.
|
Sham (no Implant)
n=14 participants at risk
Sham Posterior Segment Drug Delivery system on Day 1 in the study eye.
|
|---|---|---|---|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/15
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
6.7%
1/15
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
0.00%
0/14
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer [y]
|
0.00%
0/9
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
10.0%
1/10
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
0.00%
0/9
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/15
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
0.00%
0/15
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
7.1%
1/14
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
|
Surgical and medical procedures
Strabismus Correction
|
0.00%
0/15
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
0.00%
0/15
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
7.1%
1/14
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
Other adverse events
| Measure |
400 ug Brimonidine Implant
n=15 participants at risk
400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye.
|
200 ug Brimonidine Implant
n=15 participants at risk
200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye.
|
Sham (no Implant)
n=14 participants at risk
Sham Posterior Segment Drug Delivery system on Day 1 in the study eye.
|
|---|---|---|---|
|
Eye disorders
Conjunctival Haemorrhage
|
20.0%
3/15
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
6.7%
1/15
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
14.3%
2/14
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
|
Eye disorders
Conjunctival Hyperaemia
|
13.3%
2/15
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
6.7%
1/15
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
7.1%
1/14
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
|
Eye disorders
Eye Pruritus
|
13.3%
2/15
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
0.00%
0/15
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
0.00%
0/14
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
|
Eye disorders
Eye Pain
|
6.7%
1/15
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
20.0%
3/15
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
7.1%
1/14
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
|
Eye disorders
Hypotony of Eye
|
6.7%
1/15
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
13.3%
2/15
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
0.00%
0/14
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
|
Investigations
Intraocular Pressure Decreased
|
6.7%
1/15
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
13.3%
2/15
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
0.00%
0/14
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
|
Eye disorders
Conjunctival Oedema
|
6.7%
1/15
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
6.7%
1/15
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
7.1%
1/14
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
|
Eye disorders
Maculopathy
|
6.7%
1/15
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
6.7%
1/15
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
0.00%
0/14
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
|
Eye disorders
Cataract Subscapular
|
6.7%
1/15
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
6.7%
1/15
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
0.00%
0/14
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
|
Eye disorders
Conjunctivitis
|
6.7%
1/15
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
0.00%
0/15
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
0.00%
0/14
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
|
Eye disorders
Retinal Haemorrhage
|
6.7%
1/15
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
0.00%
0/15
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
7.1%
1/14
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
|
Eye disorders
Vitreous Floaters
|
6.7%
1/15
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
0.00%
0/15
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
7.1%
1/14
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
|
Gastrointestinal disorders
Abdominal Pain Lower
|
6.7%
1/15
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
0.00%
0/15
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
0.00%
0/14
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
|
Eye disorders
Cataract Nuclear
|
6.7%
1/15
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
0.00%
0/15
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
0.00%
0/14
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
|
Eye disorders
Eye Irritation
|
6.7%
1/15
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
0.00%
0/15
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
0.00%
0/14
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
|
General disorders
Influenza Like Illness
|
6.7%
1/15
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
0.00%
0/15
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
0.00%
0/14
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
|
Eye disorders
Keratoconjunctivitis Sicca
|
6.7%
1/15
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
0.00%
0/15
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
0.00%
0/14
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
|
Eye disorders
Optic Atrophy
|
6.7%
1/15
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
0.00%
0/15
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
0.00%
0/14
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
|
Eye disorders
Optic Disc Haemorrhage
|
6.7%
1/15
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
0.00%
0/15
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
0.00%
0/14
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
6.7%
1/15
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
0.00%
0/15
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
0.00%
0/14
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
|
Infections and infestations
Pneumonia
|
6.7%
1/15
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
0.00%
0/15
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
0.00%
0/14
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
|
Eye disorders
Vitreous Haemorrhage
|
6.7%
1/15
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
0.00%
0/15
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
0.00%
0/14
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
|
Psychiatric disorders
Depression
|
0.00%
0/15
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
13.3%
2/15
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
0.00%
0/14
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
|
Eye disorders
Posterior Capsule Opacification
|
0.00%
0/15
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
6.7%
1/15
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
0.00%
0/14
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
|
Eye disorders
Vision Blurred
|
0.00%
0/15
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
6.7%
1/15
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
7.1%
1/14
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
|
Eye disorders
Anterior Chamber Inflammation
|
0.00%
0/15
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
6.7%
1/15
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
0.00%
0/14
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
|
Infections and infestations
Cholecystitis Infective
|
0.00%
0/15
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
6.7%
1/15
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
0.00%
0/14
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
|
Eye disorders
Corneal Erosion
|
0.00%
0/15
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
6.7%
1/15
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
0.00%
0/14
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
|
Infections and infestations
Cystitis
|
0.00%
0/15
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
6.7%
1/15
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
0.00%
0/14
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/15
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
6.7%
1/15
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
0.00%
0/14
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
|
Eye disorders
Eyelid Cyst
|
0.00%
0/15
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
6.7%
1/15
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
0.00%
0/14
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/15
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
6.7%
1/15
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
0.00%
0/14
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
|
Injury, poisoning and procedural complications
Head Injury
|
0.00%
0/15
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
6.7%
1/15
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
0.00%
0/14
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
|
Renal and urinary disorders
Hypertonic Bladder
|
0.00%
0/15
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
6.7%
1/15
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
0.00%
0/14
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
|
Eye disorders
Iritis
|
0.00%
0/15
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
6.7%
1/15
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
0.00%
0/14
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
|
Infections and infestations
Pharyngitis Streptococcal
|
0.00%
0/15
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
6.7%
1/15
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
0.00%
0/14
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer
|
0.00%
0/9
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
10.0%
1/10
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
0.00%
0/9
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
|
Renal and urinary disorders
Renal Mass
|
0.00%
0/15
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
6.7%
1/15
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
0.00%
0/14
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
|
Eye disorders
Retinal Degeneration
|
0.00%
0/15
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
6.7%
1/15
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
0.00%
0/14
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
|
Eye disorders
Retinal Depigmentation
|
0.00%
0/15
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
6.7%
1/15
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
0.00%
0/14
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
|
Immune system disorders
Seasonal Allergy
|
0.00%
0/15
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
6.7%
1/15
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
0.00%
0/14
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
|
Eye disorders
Visual Impairment
|
0.00%
0/15
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
6.7%
1/15
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
0.00%
0/14
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
|
Eye disorders
Vitreous Disorder
|
0.00%
0/15
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
6.7%
1/15
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
0.00%
0/14
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
|
Eye disorders
Vitreous Opacities
|
0.00%
0/15
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
6.7%
1/15
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
0.00%
0/14
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/15
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
0.00%
0/15
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
7.1%
1/14
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
|
Eye disorders
Conjunctival Granuloma
|
0.00%
0/15
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
0.00%
0/15
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
7.1%
1/14
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
|
Eye disorders
Dry Eye
|
0.00%
0/15
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
0.00%
0/15
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
7.1%
1/14
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
|
Eye disorders
Episcleritis
|
0.00%
0/15
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
0.00%
0/15
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
7.1%
1/14
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
|
Eye disorders
Eyelid Ptosis
|
0.00%
0/15
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
0.00%
0/15
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
7.1%
1/14
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
|
Infections and infestations
Herpes Zoster
|
0.00%
0/15
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
0.00%
0/15
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
7.1%
1/14
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/15
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
0.00%
0/15
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
7.1%
1/14
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/15
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
0.00%
0/15
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
7.1%
1/14
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/15
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
0.00%
0/15
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
7.1%
1/14
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
|
Eye disorders
Iridocyclitis
|
0.00%
0/15
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
0.00%
0/15
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
7.1%
1/14
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
|
Eye disorders
Macular Oedema
|
0.00%
0/15
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
0.00%
0/15
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
7.1%
1/14
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/15
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
0.00%
0/15
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
7.1%
1/14
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/15
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
0.00%
0/15
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
7.1%
1/14
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
|
Eye disorders
Retinal Aneurysm
|
0.00%
0/15
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
0.00%
0/15
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
7.1%
1/14
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
|
Eye disorders
Scleral Disorder
|
0.00%
0/15
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
0.00%
0/15
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
7.1%
1/14
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
|
Surgical and medical procedures
Strabismus Correction
|
0.00%
0/15
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
0.00%
0/15
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
7.1%
1/14
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
|
Infections and infestations
Tooth Abscess
|
0.00%
0/15
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
0.00%
0/15
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
7.1%
1/14
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
|
Infections and infestations
Tooth Infection
|
0.00%
0/15
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
0.00%
0/15
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
7.1%
1/14
For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events are reported in the SAE section, regardless of the eye.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER