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)

• Status: Completed
• Trial end date: 2016-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alcon Research
• Treatments: Brimonidine Tartrate; Brinzolamide; Ophthalmic Solutions; Pharmaceutical Solutions; Tetrahydrozoline

Criteria

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.