Safety and Efficacy of Brinzolamide/Brimonidine Fixed Combination
Open-Angle Glaucoma, Ocular Hypertension
About this trial
This is an interventional treatment trial for Open-Angle Glaucoma focused on measuring Open-Angle Glaucoma, Ocular Hypertension, Brinzolamide, Brimonidine, Intraocular Pressure
Eligibility Criteria
Inclusion Criteria:
- Sign Informed Consent document.
- Diagnosis of open-angle glaucoma or ocular hypertension, with mean intraocular pressure within protocol-specified range at eligibility visit/s.
- Other protocol-specified inclusion criteria may apply.
Exclusion Criteria:
- Females of childbearing potential if pregnant, lactating, or not using highly effective birth control measures.
- Any form of glaucoma other than open-angle glaucoma.
- Severe central vision loss in either eye.
- Chronic, recurrent, or severe inflammatory eye disease.
- Ocular trauma within the preceding 6 months.
- Ocular infection or ocular inflammation within the preceding 3 months.
- Clinically significant or progressive retinal disease such as retinal degeneration, diabetic retinopathy, or retinal detachment.
- Best-corrected visual acuity score worse than 55 letters using the Early Treatment Diabetic Retinopathy Study chart.
- Other ocular pathology (including severe dry eye) that may, in the opinion of the Investigator, preclude the administration of study product.
- Ocular surgery within the preceding 6 months.
- Ocular laser surgery within the preceding 3 months.
- Any abnormality preventing reliable applanation tonometry.
- Any other conditions, including severe illness, which could make the patient, in the opinion of the Investigator, unsuitable for the study.
- Other protocol-specified exclusion criteria may apply.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Active Comparator
Active Comparator
Active Comparator
Brinz/Brim
Brinz
Brim
Brinz+Brim
Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension and Vehicle: 1 drop each instilled in both eyes 3 times a day for 6 weeks. A time lapse of at least 10 minutes was required between instillations of each study drug.
Brinzolamide ophthalmic suspension, 1% and Vehicle: 1 drop each instilled in both eyes 3 times a day for 6 weeks. A time lapse of at least 10 minutes was required between instillations of each study drug.
Brimonidine tartrate ophthalmic solution, 0.2% and Vehicle: 1 drop each instilled in both eyes 3 times a day for 6 weeks. A time lapse of at least 10 minutes was required between instillations of each study drug.
Brinzolamide ophthalmic suspension, 1% and brimonidine tartrate ophthalmic solution, 0.2%: 1 drop each instilled in both eyes 3 times a day for 6 weeks. A time lapse of at least 10 minutes was required between instillations of each study drug.