Safety and Efficacy of Brinzolamide/Brimonidine Fixed Combination

Launched by ALCON RESEARCH · Aug 18, 2009

Keywords

ClinConnect Summary

This study consisted of 5 visits conducted during 2 sequential phases: the screening/eligibility phase, which included a screening visit and 2 eligibility visits, and the treatment phase, which included 2 on-therapy visits conducted at Week 2 and Week 6 (or early exit). A washout period based on previous ocular medication preceded Eligibility Visit 1. Subjects who met all inclusion/exclusion criteria at both eligibility visits were randomized to 1 of 4 study drug groups for 6 weeks. Study drug instillation began the morning after the second eligibility visit. The study was terminated by the...

Gender

ALL

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.