Fixed Combination Brinzolamide 1%/Timolol 0.5% Versus Brinzolamide 1% + Timolol 0.5% in 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 compare the intraocular pressure (IOP)-lowering efficacy and safety of AZARGA™ (Brinzolamide 1%/Timolol 0.5% Ophthalmic Suspension), dosed twice daily versus AZOPT® (Brinzolamide 1% Ophthalmic Suspension) and Timolol 0.5% Ophthalmic Solution, each dosed twice daily, in Chinese patients with open-angle glaucoma or ocular hypertension who were insufficiently responsive to monotherapy.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alcon Research
• Treatments: Brinzolamide; Ophthalmic Solutions; Timolol

Criteria

Inclusion Criteria:

• Diagnosed with open angle glaucoma and/or ocular hypertension and not sufficiently responsive to monotherapy.

• Meet qualifying IOP criteria in at least 1 eye, including 21-35 mmHg at the Eligibility visit.

• Willing to sign an Informed Consent form.

• Contact lens wearer who is willing to remove lenses before instillation of study medication and wait a minimum of 15 minutes following drug instillation before re-inserting the lenses.

• Able to discontinue use of current IOP-lowering medications per the minimum washout period.

• Other protocol-specific inclusion criteria may apply.

Exclusion Criteria:

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

• Diagnosed with any form of glaucoma other than open-angle glaucoma and/or ocular hypertension.

• Diagnosed with severe central visual field loss in either eye.

• History of chronic, recurrent, or severe ocular infection, inflammatory eye disease in either eye.

• History of ocular trauma within the past 6 months in either eye.

• Current ocular infection or ocular inflammation within the past 3 months in either eye.

• Ocular laser surgery within the past 3 months.

• Intraocular surgery within the past 3 months.

• Best-corrected visual acuity score worse than 55 ETDRS letters read (equivalent to approximately 20/80 Snellen, 0.60 logMAR or 0.25 decimal).

• History of, or current clinically relevant or progressive retinal disease in either eye.

• History of, or current other severe ocular pathology (including severe dry eye) in either eye, that would preclude the administration of a topical carbonic anhydrase inhibitor (CAI) or beta-blocker.

• Any abnormality preventing reliable applanation tonometry.

• History of, or current condition or disease that would preclude the safe administration of a topical beta blocker or topical beta-adrenergic blocking agent.

• History of spontaneous or current hypoglycemia or uncontrolled diabetes.

• History of severe or serious hypersensitivity to CAIs, beta-blockers, or to any components of the study medication.

• Less than 30 days stable dosing regimen before the Screening Visit of any medications or substances administered by any route and used on a chronic basis that may have affected IOP.

• Recent use of high-dose salicylate therapy.

• Anticipated use of any additional topical or systemic ocular hypotensive medication during the study.

• Not safely able to discontinue all glucocorticoid medications administered by any route.

• Currently on therapy or have been on therapy with another investigational agent within 30 days prior to the Screening Visit.

• History of, or current evidence of severe illness or any other conditions which would, in the opinion of the Investigator, make the subject unsuitable for the study.

• Other protocol-specific exclusion criteria may apply.