Phase 2
Completed N=101
A Comfort Study of Brinzolamide 1% / Brimonidine 0.2% Fixed Combination, Brinzolamide 1% and Brimonidine 0.2%
Source: ClinicalTrials.gov NCT01426867 ↗Enrolled (actual)
101
Serious AEs
0.0%
Results posted
Jul 2013
Primary outcomePrimary: Mean Ocular Discomfort Score — 0.8; 0.4; 0.3 Units on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Ocular Discomfort Score |
0.8; 0.4; 0.3 | — |
Eligibility Criteria
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 exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT01426867). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.