Efficacy and Safety of Brinzolamide/Brimonidine Fixed Combination BID Compared to Brinzolamide BID Plus Brimonidine BID in Subjects With Open-Angle Glaucoma (OAG) or Ocular Hypertension (OHT)
This trial is active, not recruiting.
|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|
|Start date||April 2015|
|End date||October 2016|
|Trial size||376 participants|
|Trial identifier||NCT02339584, C-13-013|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||single blind (outcomes assessor)|
Mean diurnal IOP change from baseline at Month 3
time frame: Baseline (Day 0), Month 3
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.
|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.|
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