Ocular Hypertension Clinical Trial
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
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.
Status | Completed |
Enrollment | 103 |
Est. completion date | November 2011 |
Est. primary completion date | November 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Alcon Research |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mean Ocular Discomfort Score | Ocular discomfort was assessed by the subject immediately following the 8 AM instillation of study drug and rated on a 5-point scale: 0 (none), 1 (mild), 2 (moderate), 3 (severe), and 4 (very severe). | Week 1 | No |
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