A Comfort Study of Brinzolamide 1% / Brimonidine 0.2% Fixed Combination, Brinzolamide 1% and Brimonidine 0.2%
Information source: Alcon Research
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Open-Angle Glaucoma; Ocular Hypertension
Intervention: Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension (Drug); Brinzolamide ophthalmic suspension, 1% (Drug); Brimonidine tartrate ophthalmic solution, 0.2% (Drug)
Phase: Phase 2
Sponsored by: Alcon Research
Official(s) and/or principal investigator(s):
Ravaughn Williams, OD, MS, Study Director, Affiliation: Alcon Research
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.
Official title: A Descriptive Comfort Study of Brinzolamide 1% / Brimonidine Tartrate 0.2% Fixed Combination Ophthalmic Suspension, Brinzolamide 1% Ophthalmic Suspension and Brimonidine Tartrate 0.2% Ophthalmic Solution in Patients With Open-Angle Glaucoma or Ocular Hypertension
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Mean Ocular Discomfort Score
Minimum age: 18 Years.
Maximum age: N/A.
- Sign Informed Consent document.
- Diagnosis of open-angle glaucoma or ocular hypertension
- Other protocol-specified inclusion criteria may apply.
- 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.
Locations and Contacts
Starting date: September 2011
Last updated: May 17, 2013