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

Alcon

Status and phase: Completed; Phase 3

Conditions: Open-Angle Glaucoma; Ocular Hypertension

Treatments: Drug: Brinzolamide 1% ophthalmic suspension; Drug: Timolol 0.5% ophthalmic solution; Drug: Brinzolamide 1% / Timolol 0.5% fixed combination ophthalmic suspension

Study type: Interventional

Funder types: Industry

Identifiers

NCT01357616

C-08-076

Details and patient eligibility

About

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.

Full 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.

Enrollment: 328 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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328 participants in 2 patient groups

AZARGA

Experimental group

Description:

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.

Treatment:

Drug: Brinzolamide 1% / Timolol 0.5% fixed combination ophthalmic suspension

AZOPT + Timolol

Active Comparator group

Description:

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.

Treatment:

Drug: Timolol 0.5% ophthalmic solution

Drug: Brinzolamide 1% ophthalmic suspension