Clinical trial NCT01357616: Fixed Combination Brinzolamide 1%/Timolol 0.5% Versus Brinzolamide 1% + Timolol 0.5% in Open-Angle Glaucoma or Ocular Hypertension
Official title: Comparison of Efficacy and Safety of Brinzolamide/Timolol Fixed Combination (AZARGA™) vs Brinzolamide (AZOPT®) and Timolol in Chinese Subjects With Open-Angle Glaucoma or Ocular Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Open-Angle Glaucoma
Ocular Hypertension
Keywords: Glaucoma
Open-angle glaucoma
Ocular hypertension
OAG
OH
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2011-05-20
Enrollment: 328
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.
* 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.

Primary outcomes:
measure: Mean Diurnal IOP Change From Baseline at Week 8
timeFrame: Baseline, Week 8
Secondary outcomes:
measure: Mean IOP Change From Baseline at 9 AM
timeFrame: Baseline, Up to Week 8
measure: Mean IOP Change From Baseline at 11 AM
timeFrame: Baseline, Up to Week 8
measure: Mean IOP Change From Baseline (5 PM) at Week 8
timeFrame: Baseline, Week 8
Other outcomes:
Locations:
Study officials:
affiliation: Alcon Research
name: Mandy Ye, MS
role: STUDY_DIRECTOR
References: