Open-Angle Glaucoma, Ocular Hypertension
Conditions
Keywords
Open-Angle Glaucoma, Ocular Hypertension, Intraocular Pressure, Brinzolamide, Brimonidine
Brief summary
The purpose of this study was to describe the ocular discomfort immediately upon instillation of Brinzolamide 1%/Brimonidine 0.2% Tartrate Ophthalmic Suspension, Brinzolamide 1% Ophthalmic Suspension, and Brimonidine Tartrate 0.2% Ophthalmic Solution in subjects with open-angle glaucoma and/or ocular hypertension.
Interventions
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Sign Informed Consent document. * Diagnosis of open-angle glaucoma or ocular hypertension * Other protocol-specified inclusion criteria may apply.
Exclusion criteria
* Females of childbearing potential if pregnant, lactating, or not using highly effective birth control measures. * Severe central vision loss in either eye. * Any chronic or recurrent inflammatory eye disease. * Ocular trauma within the preceding 6 months. * Ocular infection or ocular inflammation within the preceding 3 months. * Best-corrected visual acuity score worse than 55 letters using the Early Treatment Diabetic Retinopathy Study chart. * Any intraocular surgery within the preceding 6 months. * Any ocular laser surgery within the preceding 3 months. * History or current evidence of severe illness or any other conditions which would make the subject, in the opinion of the Investigator, unsuitable for the study. * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Ocular Discomfort Score | Week 1 | Ocular discomfort was assessed by the subject immediately following the 8 AM instillation of study drug and rated on a 5-point scale: 0 (none), 1 (mild), 2 (moderate), 3 (severe), and 4 (very severe). |
Participant flow
Recruitment details
Subjects were recruited from 5 investigational centers in the United States.
Pre-assignment details
Of the 103 enrolled, 2 subjects did not meet inclusion/exclusion criteria and were exited from the study as screen failures prior to randomization. This reporting group includes all randomized subjects (101).
Participants by arm
| Arm | Count |
|---|---|
| Brinz/Brim Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled in each affected eye 3 times a day for 7 days | 33 |
| Brinzolamide Brinzolamide ophthalmic suspension, 1%, 1 drop instilled in each affected eye 3 times a day for 7 days | 34 |
| Brimonidine Brimonidine tartrate ophthalmic solution, 0.2%, 1 drop instilled in each affected eye 3 times a day for 7 days | 34 |
| Total | 101 |
Baseline characteristics
| Characteristic | Brinz/Brim | Brinzolamide | Brimonidine | Total |
|---|---|---|---|---|
| Age, Customized 18 to 64 years | 8 participants | 12 participants | 11 participants | 31 participants |
| Age, Customized ≥65 years | 25 participants | 22 participants | 23 participants | 70 participants |
| Region of Enrollment United States | 33 participants | 34 participants | 34 participants | 101 participants |
| Sex: Female, Male Female | 20 Participants | 23 Participants | 23 Participants | 66 Participants |
| Sex: Female, Male Male | 13 Participants | 11 Participants | 11 Participants | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 5 / 33 | 7 / 34 | 0 / 34 |
| serious Total, serious adverse events | 0 / 33 | 0 / 34 | 0 / 34 |
Outcome results
Primary
Mean Ocular Discomfort Score
Ocular discomfort was assessed by the subject immediately following the 8 AM instillation of study drug and rated on a 5-point scale: 0 (none), 1 (mild), 2 (moderate), 3 (severe), and 4 (very severe).
Time frame: Week 1
Population: Intent-to-Treat (ITT): All subjects who received study medication and had at least 1 scheduled on-therapy visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Brinz/Brim | Mean Ocular Discomfort Score | 0.8 Units on a scale | Standard Deviation 0.9 |
| Brinzolamide | Mean Ocular Discomfort Score | 0.4 Units on a scale | Standard Deviation 0.6 |
| Brimonidine | Mean Ocular Discomfort Score | 0.3 Units on a scale | Standard Deviation 0.5 |