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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

Status: Completed

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.

Clinical Details

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. Gender(s): Both.


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.

Locations and Contacts

Additional Information

Starting date: September 2011
Last updated: May 17, 2013

Page last updated: August 20, 2015

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