Fixed Combination Brinzolamide 1%/Timolol 0.5% Versus Brinzolamide 1% + Timolol 0.5% in Open-Angle Glaucoma or Ocular Hypertension

NCT ID: NCT01357616

Last Updated: 2014-04-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 328 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2013-01-31

Brief 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.

Detailed Description

The study consisted of 2 sequential phases. Phase I was the Screening/Eligibility Phase, with a Screening Visit followed by an Eligibility Visit. Phase II was the treatment phase and included Week 1, Week 2, Week 4, and Week 8 visits. Eligible subjects were randomized in a 1:1 ratio to receive Brinzolamide 1%/Timolol 0.5% or Brinzolamide 1% plus Timolol 0.5% two times a day for 8 weeks.

Conditions

Open-Angle Glaucoma; Ocular Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

AZARGA

Brinzolamide 1% / Timolol 0.5% fixed combination ophthalmic suspension, 1 drop in the affected eye(s) dosed twice daily (9AM and 9PM) for 8 weeks. Both eyes were dosed unless there was a potential safety issue to the patient in the opinion of the Investigator.

Group Type: EXPERIMENTAL

Brinzolamide 1% / Timolol 0.5% fixed combination ophthalmic suspension

Intervention Type: DRUG

AZOPT + Timolol

Brinzolamide 1% ophthalmic suspension, 1 drop instilled in the affected eye(s), followed by Timolol 0.5% ophthalmic solution, 1 drop instilled in the affected eye(s). Approximately 10 minutes separated the 2 instillations. The study drugs were instilled twice daily (9AM and 9PM) for 8 weeks. Both eyes were dosed unless there was a potential safety issue to the patient in the opinion of the Investigator.

Group Type: ACTIVE_COMPARATOR

Brinzolamide 1% ophthalmic suspension

Intervention Type: DRUG

Timolol 0.5% ophthalmic solution

Intervention Type: DRUG

Interventions

Brinzolamide 1% / Timolol 0.5% fixed combination ophthalmic suspension

Intervention Type: DRUG

Brinzolamide 1% ophthalmic suspension

Intervention Type: DRUG

Timolol 0.5% ophthalmic solution

Intervention Type: DRUG

Other Intervention Names

AZARGA™; AZOPT®; TIMOLOL

Eligibility 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.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mandy Ye, MS

Role: STUDY_DIRECTOR

Alcon Research

Other Identifiers

C-08-076

Identifier Type: -

Identifier Source: org_study_id