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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01426867
Other study ID # C-11-002
Secondary ID
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


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
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