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)
- Conditions
- Open-Angle GlaucomaOcular Hypertension
- Interventions
- Registration Number
- NCT02339584
- Lead Sponsor
- Alcon Research
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 493
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Brinz+Brim Brimonidine 2 mg/mL eye drops, solution 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 Brinz/Brim Vehicle 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 Brinz/Brim Brinzolamide 10 mg/mL / Brimonidine 2 mg/mL fixed combination eye drops, suspension 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 Brinz+Brim Brinzolamide 10 mg/mL eye drops, suspension 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
- Primary Outcome Measures
Name Time Method Mean Diurnal IOP Change From Baseline at Month 3 Baseline (Day 0), Month 3 IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in mmHg. Diurnal IOP was defined as the average of the three timepoints measured: 9 AM, +2 Hrs and +7Hrs. Baseline was the average of the values for 2 eligibility visits. If one of the values was missing, the other non-missing value was taken as the baseline. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates greater improvement, ie, a reduction of IOP. Only one eye (study eye) contributed to the analysis.
- Secondary Outcome Measures
Name Time Method