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

NCT01426867 | Completed Phase 2 Results

• 1 other identifier: C-11-002
• Study Type: interventional
• Target: 103
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Open-Angle Glaucoma; Ocular Hypertension

Keywords

Open-Angle Glaucoma; Ocular Hypertension; Intraocular Pressure; Brinzolamide; Brimonidine

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Brinz/Brim

EXPERIMENTAL

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

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

Brinzolamide

ACTIVE COMPARATOR

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

Drug: Brinzolamide ophthalmic suspension, 1%

Brimonidine

ACTIVE COMPARATOR

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

Drug: Brimonidine tartrate ophthalmic solution, 0.2%

Interventions

Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension DRUG

Brinz/Brim

Brinzolamide ophthalmic suspension, 1% DRUG

Brinzolamide

Brimonidine tartrate ophthalmic solution, 0.2% DRUG

Brimonidine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Sign Informed Consent document.
• Diagnosis of open-angle glaucoma or ocular hypertension

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alcon Research: lead

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension

Interventions

brinzolamide; Brimonidine Tartrate

Condition Hierarchy (Ancestors)

Glaucoma; Eye Diseases

Intervention Hierarchy (Ancestors)

Quinoxalines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Matt Walker, PhD, Clinical Project Lead
• Organization: Alcon Research, Ltd.

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Ravaughn Williams, OD, MS

  Alcon Research

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2011
• First Posted: September 1, 2011
• Study Start: September 1, 2011
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: July 8, 2013
• Results First Posted: July 8, 2013

Record last verified: 2013-05