Safety and Efficacy of Brinzolamide/Brimonidine Fixed Combination

Phase 2TerminatedNCT00961649

Alcon Research195 enrolled

Overview

The purpose of this study was to compare the safety and intraocular pressure (IOP)-lowering efficacy of a new fixed combination of brinzolamide/brimonidine (Brinz/Brim) to: * its individual components (Brinz and Brim), and * the concomitant administration of Brinz and Brim (Brinz+Brim).

This study consisted of 5 visits conducted during 2 sequential phases: the screening/eligibility phase, which included a screening visit and 2 eligibility visits, and the treatment phase, which included 2 on-therapy visits conducted at Week 2 and Week 6 (or early exit). A washout period based on previous ocular medication preceded Eligibility Visit 1. Subjects who met all inclusion/exclusion criteria at both eligibility visits were randomized to 1 of 4 study drug groups for 6 weeks. Study drug instillation began the morning after the second eligibility visit. The study was terminated by the sponsor out of caution due to microgel formation in the Brinz/Brim formulation. 13 remaining active subjects were discontinued. Further analysis revealed that neither the drop size nor the concentration of the active ingredients was affected.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

195

Conditions

Open-Angle Glaucoma Ocular Hypertension

Interventions

Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspensionDRUG

Brinzolamide ophthalmic suspension, 1%DRUG

Brimonidine tartrate ophthalmic solution, 0.2%DRUG

Vehicle

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Sign Informed Consent document. * Diagnosis of open-angle glaucoma or ocular hypertension, with mean intraocular pressure within protocol-specified range at eligibility visit/s. * Other protocol-specified inclusion criteria may apply. Exclusion Criteria: * Females of childbearing potential if pregnant, lactating, or not using highly effective birth control measures. * Any form of glaucoma other than open-angle glaucoma. * Severe central vision loss in either eye. * Chronic, recurrent, or severe inflammatory eye disease. * Ocular trauma within the preceding 6 months. * Ocular infection or ocular inflammation within the preceding 3 months. * Clinically significant or progressive retinal disease such as retinal degeneration, diabetic retinopathy, or retinal detachment. * Best-corrected visual acuity score worse than 55 letters using the Early Treatment Diabetic Retinopathy Study chart. * Other ocular pathology (including severe dry eye) that may, in the opinion of the Investigator, preclude the administration of study product. * Ocular surgery within the preceding 6 months. * Ocular laser surgery within the preceding 3 months. * Any abnormality preventing reliable applanation tonometry. * Any other conditions, including severe illness, which could make the patient, in the opinion of the Investigator, unsuitable for the study. * Other protocol-specified exclusion criteria may apply.

Outcomes

Primary Outcomes

Mean Change in Intraocular Pressure (IOP) From Baseline to Each of the Assessment Time Points (8 AM, + 2 Hrs, + 7 Hrs, and + 9 Hrs) at Week 6 - Brinz/Brim, Brinz, Brim

The study drug was instilled at 8 AM and +7 hours relative to the 8 AM dosing (approximately 15 minutes after conducting the IOP measurements). Intraocular pressure was measured by Goldmann applanation tonometry. One eye from each patient was chosen as the study eye and only data for the study eye were used for the efficacy analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). Intent-to-Treat (ITT) analysis data set was pre-specified for the comparison of Brinz/Brim to its individual components (Brinz and Brim).

Time frame: Baseline, Week 6

Mean Change in Intraocular Pressure (IOP) From Baseline to Each of the Assessment Time Points (8 AM, +2 Hrs, +7 Hrs, and +9 Hrs) at Week 6 - Brinz/Brim, Brinz+Brim

The study drug was instilled at 8 AM and +7 hours relative to the 8 AM dosing (approximately 15 minutes after conducting the IOP measurements). Intraocular pressure was measured by Goldmann applanation tonometry. One eye from each patient was chosen as the study eye and only data for the study eye were used for the efficacy analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). Per-Protocol (PP) analysis data set was pre-specified for the comparison of Brinz/Brim to Brinz+Brim.

Time frame: Baseline, Week 6

Data from ClinicalTrials.gov

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