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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01426867
• Other study ID #: C-11-002
• Status: Completed
• Phase: Phase 2
• First received: August 24, 2011
• Last updated: May 17, 2013
• Start date: September 2011
• Est. completion date: November 2011

Study information

• Verified date: May 2013
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Hypertension
• Ocular Hypertension
• Open-Angle Glaucoma

Intervention

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

• Brinzolamide ophthalmic suspension, 1%

• Brimonidine tartrate ophthalmic solution, 0.2%

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Outcome

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