Fixed Combination Brinzolamide 1%/Timolol 0.5% Versus Brinzolamide 1% + Timolol 0.5% in Open-Angle Glaucoma or Ocular Hypertension
Open-Angle Glaucoma, Ocular Hypertension
About this trial
This is an interventional treatment trial for Open-Angle Glaucoma focused on measuring Glaucoma, Open-angle glaucoma, Ocular hypertension, OAG, OH
Eligibility Criteria
Inclusion Criteria:
- Diagnosed with open angle glaucoma and/or ocular hypertension and not sufficiently responsive to monotherapy.
- Meet qualifying IOP criteria in at least 1 eye, including 21-35 mmHg at the Eligibility visit.
- Willing to sign an Informed Consent form.
- Contact lens wearer who is willing to remove lenses before instillation of study medication and wait a minimum of 15 minutes following drug instillation before re-inserting the lenses.
- Able to discontinue use of current IOP-lowering medications per the minimum washout period.
- Other protocol-specific inclusion criteria may apply.
Exclusion Criteria:
- Women of childbearing potential if pregnant, test positive for pregnancy at Screening/Enrollment visit, breastfeeding, or not in agreement to use adequate birth control methods to prevent pregnancy throughout the study.
- Diagnosed with any form of glaucoma other than open-angle glaucoma and/or ocular hypertension.
- Diagnosed with severe central visual field loss in either eye.
- History of chronic, recurrent, or severe ocular infection, inflammatory eye disease in either eye.
- History of ocular trauma within the past 6 months in either eye.
- Current ocular infection or ocular inflammation within the past 3 months in either eye.
- Ocular laser surgery within the past 3 months.
- Intraocular surgery within the past 3 months.
- Best-corrected visual acuity score worse than 55 ETDRS letters read (equivalent to approximately 20/80 Snellen, 0.60 logMAR or 0.25 decimal).
- History of, or current clinically relevant or progressive retinal disease in either eye.
- History of, or current other severe ocular pathology (including severe dry eye) in either eye, that would preclude the administration of a topical carbonic anhydrase inhibitor (CAI) or beta-blocker.
- Any abnormality preventing reliable applanation tonometry.
- History of, or current condition or disease that would preclude the safe administration of a topical beta blocker or topical beta-adrenergic blocking agent.
- History of spontaneous or current hypoglycemia or uncontrolled diabetes.
- History of severe or serious hypersensitivity to CAIs, beta-blockers, or to any components of the study medication.
- Less than 30 days stable dosing regimen before the Screening Visit of any medications or substances administered by any route and used on a chronic basis that may have affected IOP.
- Recent use of high-dose salicylate therapy.
- Anticipated use of any additional topical or systemic ocular hypotensive medication during the study.
- Not safely able to discontinue all glucocorticoid medications administered by any route.
- Currently on therapy or have been on therapy with another investigational agent within 30 days prior to the Screening Visit.
- History of, or current evidence of severe illness or any other conditions which would, in the opinion of the Investigator, make the subject unsuitable for the study.
- Other protocol-specific exclusion criteria may apply.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
AZARGA
AZOPT + Timolol
Brinzolamide 1% / Timolol 0.5% fixed combination ophthalmic suspension, 1 drop in the affected eye(s) dosed twice daily (9AM and 9PM) for 8 weeks. Both eyes were dosed unless there was a potential safety issue to the patient in the opinion of the Investigator.
Brinzolamide 1% ophthalmic suspension, 1 drop instilled in the affected eye(s), followed by Timolol 0.5% ophthalmic solution, 1 drop instilled in the affected eye(s). Approximately 10 minutes separated the 2 instillations. The study drugs were instilled twice daily (9AM and 9PM) for 8 weeks. Both eyes were dosed unless there was a potential safety issue to the patient in the opinion of the Investigator.