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

Alcon

Status and phase: Completed; Phase 2

Conditions: Open-Angle Glaucoma; Ocular Hypertension

Treatments: Drug: Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension; Drug: Brimonidine tartrate ophthalmic solution, 0.2%; Drug: Brinzolamide ophthalmic suspension, 1%

Study type: Interventional

Funder types: Industry

Identifiers

NCT01426867

C-11-002

Details and patient eligibility

About

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.

Enrollment: 103 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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103 participants in 3 patient groups

Brinz/Brim

Experimental group

Description:

Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled in each affected eye 3 times a day for 7 days

Treatment:

Drug: Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension

Brinzolamide

Active Comparator group

Description:

Brinzolamide ophthalmic suspension, 1%, 1 drop instilled in each affected eye 3 times a day for 7 days

Treatment:

Drug: Brinzolamide ophthalmic suspension, 1%

Brimonidine

Active Comparator group

Description:

Brimonidine tartrate ophthalmic solution, 0.2%, 1 drop instilled in each affected eye 3 times a day for 7 days

Treatment:

Drug: Brimonidine tartrate ophthalmic solution, 0.2%