Overview

Efficacy and Safety Study of Brinzolamide 1%/Brimonidine 0.2% vs. Brinzolamide 1% and Brimonidine 0.2%

Status:
Completed
Trial end date:
2012-03-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study was to evaluate the efficacy and safety of a fixed combination of Brinzolamide/Brimonidine in lowering intraocular pressure (IOP) relative to each of its individual active components in patients with open-angle glaucoma and/or ocular hypertension.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Alcon Research
Treatments:
Brimonidine Tartrate
Brinzolamide
Ophthalmic Solutions
Criteria
Inclusion Criteria:

- Sign Informed Consent document.

- Diagnosis of open-angle glaucoma or ocular hypertension, with mean intraocular
pressure within protocol-specified range at eligibility visit/s.

- Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

- Females of childbearing potential if pregnant, lactating, or not using highly
effective birth control measures.

- Any form of glaucoma other than open-angle glaucoma.

- Severe central vision loss in either eye.

- Chronic, recurrent, or severe inflammatory eye disease.

- Ocular trauma within the preceding 6 months.

- Ocular infection or ocular inflammation within the preceding 3 months.

- Clinically significant or progressive retinal disease such as retinal degeneration,
diabetic retinopathy, or retinal detachment.

- Best-corrected visual acuity score worse than 55 letters using the Early Treatment
Diabetic Retinopathy Study chart.

- Other ocular pathology (including severe dry eye) that may, in the opinion of the
Investigator, preclude the administration of study product.

- Ocular surgery within the preceding 6 months.

- Ocular laser surgery within the preceding 3 months.

- Any abnormality preventing reliable applanation tonometry.

- Any other conditions, including severe illness, which could make the patient, in the
opinion of the Investigator, unsuitable for the study.

- Other protocol-specified exclusion criteria may apply.