Trial Outcomes & Findings for An Exploratory Study to Evaluate the Safety of Brimonidine Intravitreal Implant in Patients With Retinitis Pigmentosa (NCT NCT00661479)
NCT ID: NCT00661479
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) 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.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
21 participants
Primary outcome timeframe
Baseline, Month 6
Results posted on
2013-04-24
Participant Flow
Patients were stratified by Best Corrected Visual Acuity (BCVA). Patients assigned to Group A had a BCVA of 20/320. Patients assigned to Group B had a BCVA worse than 20/40 and better than 20/320. Patients in Group A were randomized and treated prior to initiating enrollment in Group B. No patients from Group A participated in Group B.
Participant milestones
| Measure |
400 µg Brimonidine Tartrate Implant Group B
400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
|
200 µg Brimonidine Tartrate Implant Group B
200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
|
100 µg Brimonidine Tartrate Implant Group B
100 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
|
100 µg Brimonidine Tartrate Implant Group A
100 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
12
|
3
|
3
|
3
|
|
Overall Study
COMPLETED
|
12
|
3
|
3
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
An Exploratory Study to Evaluate the Safety of Brimonidine Intravitreal Implant in Patients With Retinitis Pigmentosa
Baseline characteristics by cohort
| Measure |
400 µg Brimonidine Tartrate Implant Group B
n=12 Participants
400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
|
200 µg Brimonidine Tartrate Implant Group B
n=3 Participants
200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
|
100 µg Brimonidine Tartrate Implant Group B
n=3 Participants
100 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
|
100 µg Brimonidine Tartrate Implant Group A
n=3 Participants
100 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age Continuous
|
46.3 Years
STANDARD_DEVIATION 18.70 • n=5 Participants
|
56.3 Years
STANDARD_DEVIATION 6.03 • n=7 Participants
|
48.7 Years
STANDARD_DEVIATION 4.04 • n=5 Participants
|
69.0 Years
STANDARD_DEVIATION 5.29 • n=4 Participants
|
51.3 Years
STANDARD_DEVIATION 16.36 • n=21 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline, Month 6Population: Safety Population: all patients treated on Day 1
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 µg Brimonidine Tartrate Implant Group B
n=12 Participants
400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
|
200 µg Brimonidine Tartrate Implant Group B
n=3 Participants
200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
|
100 µg Brimonidine Tartrate Implant Group B
n=3 Participants
100 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
|
100 µg Brimonidine Tartrate Implant Group A
n=3 Participants
100 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
|
|---|---|---|---|---|
|
Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye
Baseline
|
48.5 Number of Letters Read Correctly
Standard Deviation 14.61
|
51.0 Number of Letters Read Correctly
Standard Deviation 14.18
|
52.7 Number of Letters Read Correctly
Standard Deviation 3.79
|
4.0 Number of Letters Read Correctly
Standard Deviation 3.46
|
|
Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye
Change from Baseline at Month 6
|
3.2 Number of Letters Read Correctly
Standard Deviation 4.41
|
-1.3 Number of Letters Read Correctly
Standard Deviation 4.04
|
3.3 Number of Letters Read Correctly
Standard Deviation 8.50
|
0.3 Number of Letters Read Correctly
Standard Deviation 3.79
|
SECONDARY outcome
Timeframe: Baseline, Month 6Population: Safety Population: all patients treated on Day 1
Change from baseline in contrast sensitivity in the study eye is measured using a Pelli-Robson contrast sensitivity chart at 1 meter. The contrast sensitivity chart contains letters that are darkest at the top and then get progressively lighter. Scores range from 0 to 48 and are based on the number of letters read correctly. A negative change from baseline indicates a worsening in contrast sensitivity and a positive change from baseline indicates an improvement.
Outcome measures
| Measure |
400 µg Brimonidine Tartrate Implant Group B
n=12 Participants
400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
|
200 µg Brimonidine Tartrate Implant Group B
n=3 Participants
200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
|
100 µg Brimonidine Tartrate Implant Group B
n=3 Participants
100 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
|
100 µg Brimonidine Tartrate Implant Group A
n=3 Participants
100 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
|
|---|---|---|---|---|
|
Change From Baseline in Contrast Sensitivity in the Study Eye
Change from Baseline at Month 6
|
0.8 Number of Letters Read Correctly
Standard Deviation 4.86
|
-0.3 Number of Letters Read Correctly
Standard Deviation 5.86
|
4.3 Number of Letters Read Correctly
Standard Deviation 1.15
|
-2.0 Number of Letters Read Correctly
Standard Deviation 1.73
|
|
Change From Baseline in Contrast Sensitivity in the Study Eye
Baseline
|
15.5 Number of Letters Read Correctly
Standard Deviation 8.48
|
18.0 Number of Letters Read Correctly
Standard Deviation 7.21
|
22.3 Number of Letters Read Correctly
Standard Deviation 1.53
|
3.0 Number of Letters Read Correctly
Standard Deviation 3.46
|
Adverse Events
400 µg Brimonidine Tartrate Implant Group B
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
200 µg Brimonidine Tartrate Implant Group B
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
100 µg Brimonidine Tartrate Implant Groups A and B
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
400 µg Brimonidine Tartrate Implant Group B
n=12 participants at risk
400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
|
200 µg Brimonidine Tartrate Implant Group B
n=3 participants at risk
200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
|
100 µg Brimonidine Tartrate Implant Groups A and B
n=6 participants at risk
100 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
|
|---|---|---|---|
|
Nervous system disorders
Syncope
|
8.3%
1/12
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
0.00%
0/3
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
0.00%
0/6
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
|
Nervous system disorders
Myelitis
|
0.00%
0/12
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
0.00%
0/3
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
16.7%
1/6
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
Other adverse events
| Measure |
400 µg Brimonidine Tartrate Implant Group B
n=12 participants at risk
400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
|
200 µg Brimonidine Tartrate Implant Group B
n=3 participants at risk
200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
|
100 µg Brimonidine Tartrate Implant Groups A and B
n=6 participants at risk
100 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Wound
|
8.3%
1/12
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
0.00%
0/3
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
0.00%
0/6
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
|
Eye disorders
Visual Disturbance
|
8.3%
1/12
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
0.00%
0/3
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
0.00%
0/6
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
|
Eye disorders
Conjunctival Haemorrhage
|
41.7%
5/12
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
66.7%
2/3
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
16.7%
1/6
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
|
Eye disorders
Conjunctival Hyperaemia
|
41.7%
5/12
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
100.0%
3/3
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
83.3%
5/6
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
|
Eye disorders
Foreign Body Sensation in Eyes
|
25.0%
3/12
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
0.00%
0/3
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
16.7%
1/6
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
|
Eye disorders
Ocular Discomfort
|
25.0%
3/12
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
0.00%
0/3
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
16.7%
1/6
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
|
Infections and infestations
Nasopharyngitis
|
25.0%
3/12
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
0.00%
0/3
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
33.3%
2/6
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
|
General disorders
Fatigue
|
16.7%
2/12
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
0.00%
0/3
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
0.00%
0/6
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
|
Eye disorders
Glare
|
16.7%
2/12
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
0.00%
0/3
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
0.00%
0/6
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
|
Gastrointestinal disorders
Nausea
|
16.7%
2/12
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
0.00%
0/3
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
0.00%
0/6
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
|
Eye disorders
Eye Pain
|
16.7%
2/12
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
0.00%
0/3
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
33.3%
2/6
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
|
Eye disorders
Conjunctival Oedema
|
16.7%
2/12
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
66.7%
2/3
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
16.7%
1/6
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
|
Gastrointestinal disorders
Abdominal pain
|
8.3%
1/12
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
0.00%
0/3
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
0.00%
0/6
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
8.3%
1/12
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
0.00%
0/3
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
0.00%
0/6
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
|
Psychiatric disorders
Anxiety
|
8.3%
1/12
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
0.00%
0/3
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
0.00%
0/6
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
|
Injury, poisoning and procedural complications
Bite
|
8.3%
1/12
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
0.00%
0/3
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
0.00%
0/6
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
|
Congenital, familial and genetic disorders
Colour Blindness
|
8.3%
1/12
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
0.00%
0/3
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
0.00%
0/6
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
|
Eye disorders
Conjunctivitis Allergic
|
8.3%
1/12
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
0.00%
0/3
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
0.00%
0/6
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
|
Metabolism and nutrition disorders
Dehydration
|
8.3%
1/12
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
0.00%
0/3
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
0.00%
0/6
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Allergic
|
8.3%
1/12
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
0.00%
0/3
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
0.00%
0/6
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
|
Nervous system disorders
Dizziness
|
8.3%
1/12
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
0.00%
0/3
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
0.00%
0/6
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
|
Eye disorders
Dry Eye
|
8.3%
1/12
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
0.00%
0/3
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
0.00%
0/6
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
|
Reproductive system and breast disorders
Epididymitis
|
14.3%
1/7
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
0.00%
0/2
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
0.00%
0/3
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
|
Eye disorders
Eye Irritation
|
8.3%
1/12
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
0.00%
0/3
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
0.00%
0/6
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
|
Injury, poisoning and procedural complications
Foot Fracture
|
8.3%
1/12
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
0.00%
0/3
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
0.00%
0/6
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
|
Nervous system disorders
Headache
|
8.3%
1/12
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
0.00%
0/3
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
0.00%
0/6
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
|
Psychiatric disorders
Insomnia
|
8.3%
1/12
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
0.00%
0/3
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
0.00%
0/6
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
|
Eye disorders
Lacrimation Increased
|
8.3%
1/12
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
0.00%
0/3
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
0.00%
0/6
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
|
Injury, poisoning and procedural complications
Ligament Injury
|
8.3%
1/12
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
0.00%
0/3
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
0.00%
0/6
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.3%
1/12
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
0.00%
0/3
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
0.00%
0/6
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
|
Nervous system disorders
Neuropathy Peripheral
|
8.3%
1/12
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
0.00%
0/3
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
0.00%
0/6
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
|
Vascular disorders
Orthostatic Hypotension
|
8.3%
1/12
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
0.00%
0/3
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
0.00%
0/6
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal Pain
|
8.3%
1/12
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
0.00%
0/3
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
0.00%
0/6
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
|
Infections and infestations
Rhinitis
|
8.3%
1/12
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
0.00%
0/3
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
0.00%
0/6
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
|
Nervous system disorders
Syncope
|
8.3%
1/12
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
0.00%
0/3
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
0.00%
0/6
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
|
Ear and labyrinth disorders
Tinnitus
|
8.3%
1/12
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
0.00%
0/3
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
0.00%
0/6
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
|
Eye disorders
Vision Blurred
|
8.3%
1/12
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
0.00%
0/3
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
0.00%
0/6
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
|
Eye disorders
Abnormal Sensation in Eye
|
0.00%
0/12
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
0.00%
0/3
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
16.7%
1/6
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
|
Infections and infestations
Bacteriuria
|
0.00%
0/12
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
0.00%
0/3
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
16.7%
1/6
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/12
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
0.00%
0/3
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
16.7%
1/6
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
|
Ear and labyrinth disorders
Ear Pain
|
0.00%
0/12
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
0.00%
0/3
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
16.7%
1/6
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/12
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
0.00%
0/3
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
16.7%
1/6
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
|
General disorders
Influenza Like Illness
|
0.00%
0/12
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
0.00%
0/3
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
16.7%
1/6
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
|
Eye disorders
Keratitis
|
0.00%
0/12
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
0.00%
0/3
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
16.7%
1/6
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
|
Musculoskeletal and connective tissue disorders
Muscle Contracture
|
0.00%
0/12
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
0.00%
0/3
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
16.7%
1/6
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
|
Nervous system disorders
Myelitis
|
0.00%
0/12
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
0.00%
0/3
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
16.7%
1/6
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/12
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
0.00%
0/3
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
16.7%
1/6
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
|
Infections and infestations
Prostate Infection
|
0.00%
0/7
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
0.00%
0/2
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
33.3%
1/3
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
|
Injury, poisoning and procedural complications
Renal Injury
|
0.00%
0/12
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
0.00%
0/3
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
16.7%
1/6
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
|
Nervous system disorders
Restless Legs Syndrome
|
0.00%
0/12
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
0.00%
0/3
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
16.7%
1/6
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis Allergic
|
0.00%
0/12
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
0.00%
0/3
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
16.7%
1/6
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/12
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
0.00%
0/3
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
16.7%
1/6
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/12
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
0.00%
0/3
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
16.7%
1/6
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
|
Eye disorders
Visual Acuity Reduced
|
0.00%
0/12
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
0.00%
0/3
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
16.7%
1/6
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
|
Eye disorders
Vitreous Floaters
|
0.00%
0/12
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
0.00%
0/3
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
16.7%
1/6
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/12
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
33.3%
1/3
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
0.00%
0/6
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
|
Gastrointestinal disorders
Dental Caries
|
0.00%
0/12
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
33.3%
1/3
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
0.00%
0/6
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/12
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
33.3%
1/3
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
|
0.00%
0/6
For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of 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