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.