Overview

Brinzolamide/Brimonidine Twice a Day (BID) Fixed Combination (FC) vs Brinzolamide BID Plus Brimonidine BID in Patients With Open Angle Glaucoma or Ocular Hypertension

Status:
Completed
Trial end date:
2013-01-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study was to evaluate the safety and efficacy of Brinzolamide/Brimonidine fixed combination in lowering intraocular pressure (IOP) relative to each of its individual active constituents instilled concomitantly (Brinzolamide+Brimonidine) in patients with open-angle glaucoma or ocular hypertension.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Alcon Research
Treatments:
Brimonidine Tartrate
Brinzolamide
Ophthalmic Solutions
Pharmaceutical Solutions
Criteria
Inclusion Criteria:

- Diagnosed with open-angle glaucoma or ocular hypertension and, in the opinion of the
Investigator, are insufficiently controlled on monotherapy or are currently on
multiple IOP-lowering medications.

- Meet qualifying IOP entry criteria.

- Able to understand and sign an informed consent form.

- Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

- Women of childbearing potential if pregnant, test positive for pregnancy at Screening
visit, breastfeeding, or not in agreement to use adequate birth control methods to
prevent pregnancy throughout the study.

- Severe central visual field loss.

- Can not safely undergo the initial washout period and discontinue use of all
IOP-lowering ocular medication(s) for the minimum specified period prior to
Eligibility Visit 1.

- Best corrected visual acuity (BCVA) score worse than 55 ETDRS letters (20/80 Snellen
equivalent).

- Chronic, recurrent or severe inflammatory eye disease.

- Ocular trauma within the preceding 6 months.

- Ocular infection or inflammation within the preceding 3 months.

- Clinically significant or progressive retinal disease.

- Other ocular pathology.

- Intraocular surgery within the 6 months prior to entry.

- Ocular laser surgery within the 3 months prior to entry.

- Any abnormality preventing reliable applanation tonometry.

- Any other conditions which would make the patient, in the opinion of the Investigator,
unsuitable for the study.

- Recent use of high-dose (>1 gram daily) salicylate therapy.

- Recent, current, or anticipated treatment with any medication that augments adrenergic
responses, or precludes use of an alpha-adrenergic agonist.

- Other protocol-specified exclusion criteria may apply.