Overview

This trial has been completed.

Conditions open-angle glaucoma, ocular hypertension
Treatments brinzolamide 10 mg/ml / brimonidine 2 mg/ml fixed combination eye drops, suspension, brinzolamide 10 mg/ml eye drops, suspension, brimonidine 2 mg/ml eye drops, solution, vehicle
Phase phase 3
Sponsor Alcon Research
Start date April 2015
End date November 2016
Trial size 493 participants
Trial identifier NCT02339584, C-13-013

Summary

The purpose of this study is to compare the fixed combination (BID) [Brinzolamide 10 mg/mL / Brimonidine 2 mg/mL eyes drops, suspension] to the unfixed combination (BID) [Brinzolamide 10 mg/mL eye drops, suspension plus Brimonidine 2 mg/mL eyes drops, solution] with respect to intraocular pressure (IOP)-lowering efficacy. This study will take place in China, Taiwan, and Russia.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Vehicle solution, 1 drop, followed by Brinzolamide 10 mg/mL / Brimonidine 2 mg/mL fixed combination eye drops, suspension, 1 drop, administered at least 5 minutes apart in the treated eye(s) twice daily (BID) for 3 months
brinzolamide 10 mg/ml / brimonidine 2 mg/ml fixed combination eye drops, suspension
vehicle
Inactive ingredients used as a placebo for masking purposes
(Active Comparator)
Brimonidine 2 mg/mL eye drops, solution, 1 drop, followed by Brinzolamide 10 mg/mL eye drops, suspension, 1 drop, administered at least 5 minutes apart in the treated eye(s) BID for 3 months
brinzolamide 10 mg/ml eye drops, suspension AZOPT™
brimonidine 2 mg/ml eye drops, solution

Primary Outcomes

Measure
Mean diurnal IOP change from baseline at Month 3
time frame: Baseline (Day 0), Month 3

Eligibility Criteria

Male or female participants from 18 years up to 95 years old.

Inclusion Criteria: - Diagnosis of open-angle glaucoma or ocular hypertension insufficiently controlled on monotherapy or currently on multiple IOP-lowering medications; - Mean IOP measurements within guidelines specified in the protocol. Must not be > 36 mmHg at any time point; - Able to understand and sign an informed consent form; - Other protocol-specified inclusion criteria may apply. Exclusion Criteria: - Women of childbearing potential who are pregnant, test positive for pregnancy, intend to become pregnant during the study period, breast-feeding, or not in agreement to use adequate birth control methods throughout the study; - Severe central visual field loss in either eye; - Unable to safely discontinue all IOP-lowering ocular medication(s) for a minimum of 5 (± 1) to 28 (± 1) days prior to E1 Visit; - Chronic, recurrent or severe inflammatory eye disease; - Ocular trauma within the past 6 months; - Ocular infection or ocular inflammation within the past 3 months; - Clinically significant or progressive retinal disease such as retinal degeneration, diabetic retinopathy, or retinal detachment; - Best-corrected visual acuity (BCVA) score worse than 55 ETDRS letters (equivalent to approximately 0.60 logMAR, 20/80 Snellen, or 0.25 decimal); - Other ocular pathology (including severe dry eye) that may preclude the administration of α-adrenergic agonist and/or topical carbonic anhydrase inhibitor (CAI); - Intraocular surgery within the past 6 months; - Ocular laser surgery within the past 3 months; - Any abnormality preventing reliable applanation tonometry; - Any conditions including severe illness which would make the Subject, in the opinion of the Investigator, unsuitable for the study; - History of active, severe, unstable or uncontrolled cardiovascular, cerebrovascular, hepatic, or renal disease that would preclude safe administration of a topical α-adrenergic agonist or CAI; - Recent (within 4 weeks of the E1 Visit) use of high-dose (> 1 g daily) salicylate therapy; - Current or anticipated treatment with any psychotropic drugs that augment adrenergic response (eg, desipramine, amitriptyline); - Concurrent use of monoamine oxidase inhibitors (MAOI); - Concurrent use of glucocorticoids administered by any route; - Therapy with another investigational agent within 30 days prior to the Screening Visit; - Hypersensitivity to α-adrenergic agonist drugs, topical or oral CAIs, sulfonamide derivatives, or to any component of the study medications; - Less than 30 days stable dosing regimen before the Screening Visit of any medications (excluding IOP-lowering treatments) or substances administered by any route and used on a chronic basis that may affect IOP, including but not limited to β-adrenergic blocking agents; - Use of any additional topical or systemic ocular hypotensive medication during the study; - Other protocol-specified exclusion criteria may apply.

Additional Information

Official title Efficacy and Safety of Brinzolamide 10 mg/mL / Brimonidine 2 mg/mL Eye Drops, Suspension Compared to Brinzolamide 10 mg/mL Eye Drops, Suspension Plus Brimonidine 2 mg/mL Eye Drops, Solution in Subjects With Open-Angle Glaucoma or Ocular Hypertension
Description This study is divided into 2 phases conducted in sequence for a total of 6 visits: Phase I (Screening/Eligibility) which includes a Screening Visit, followed by 2 Eligibility Visits (E1 and E2) and Phase II (Treatment/Follow-up) which includes 3 visits at Week 2, Week 6, and Month 3. Following washout of any IOP-lowering medication, subjects who meet all inclusion/exclusion criteria at both Eligibility visits and had IOP measurements within the specified range during this period will be randomized to Phase II.
Trial information was received from ClinicalTrials.gov and was last updated in December 2016.
Information provided to ClinicalTrials.gov by Alcon Research.