Phase 2 N=101 Randomized Triple-blind Treatment

A Comfort Study of Brinzolamide 1% / Brimonidine 0.2% Fixed Combination, Brinzolamide 1% and Brimonidine 0.2%

Open-Angle Glaucoma · Ocular Hypertension

Bottom Line

View on ClinicalTrials.gov: NCT01426867 ↗

Enrolled (actual)

101

Serious AEs

0.0%

Results posted

Jul 2013

Primary outcome: Primary: Mean Ocular Discomfort Score — 0.8; 0.4; 0.3 Units on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension (Drug); Brinzolamide ophthalmic suspension, 1% (Drug); Brimonidine tartrate ophthalmic solution, 0.2% (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Alcon Research
Primary completion: Nov 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean Ocular Discomfort Score	0.8; 0.4; 0.3	—

Summary

The purpose of this study was to describe the ocular discomfort immediately upon instillation of Brinzolamide 1%/Brimonidine 0.2% Tartrate Ophthalmic Suspension, Brinzolamide 1% Ophthalmic Suspension, and Brimonidine Tartrate 0.2% Ophthalmic Solution in subjects with open-angle glaucoma and/or ocular hypertension.

Eligibility Criteria

Inclusion Criteria

Sign Informed Consent document.
Diagnosis of open-angle glaucoma or ocular hypertension
Other protocol-specified inclusion criteria may apply.

Exclusion Criteria

Females of childbearing potential if pregnant, lactating, or not using highly effective birth control measures.
Severe central vision loss in either eye.
Any chronic or recurrent inflammatory eye disease.
Ocular trauma within the preceding 6 months.
Ocular infection or ocular inflammation within the preceding 3 months.
Best-corrected visual acuity score worse than 55 letters using the Early Treatment Diabetic Retinopathy Study chart.
Any intraocular surgery within the preceding 6 months.
Any ocular laser surgery within the preceding 3 months.
History or current evidence of severe illness or any other conditions which would make the subject, in the opinion of the Investigator, unsuitable for the study.
Other protocol-defined exclusion criteria may apply.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01426867). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.