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NCT00314158 Clinical Trial

A Study of a Glaucoma Therapy to Treat Open-Angle Glaucoma or Ocular Hypertension

Ocular Hypertension Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00314158
Other study ID # C-05-24
Secondary ID
Status Completed
Phase Phase 3
First received April 10, 2006
Last updated November 17, 2016
Start date November 2005
Est. completion date January 2007

Study information
Verified date March 2012
Source Alcon Research
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine whether a glaucoma therapy is safe and effective in treating patients with open-angle glaucoma or ocular hypertension.

Recruitment information / eligibility
Status Completed
Enrollment 523
Est. completion date January 2007
Est. primary completion date January 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 18 years of age or older

- Diagnosis of open-angle glaucoma

- Other protocol-defined inclusion criteria may apply

Exclusion Criteria:

- Under 18

- Pregnant

- Other protocol-defined exclusion criteria may apply

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Brinzolamide 10 mg/ml + Timolol 5 mg/ml eye drops, suspension
One drop twice daily in each study eye for six months
• Brinzolamide 10 mg/ml (AZOPT) eye drops, suspension
One drop twice daily in each study eye for six months
• Timolol 5 mg/ml eye drops, solution
One drop twice daily in each study eye for six months

Locations
Country Name City State
United States United States Investigative Sites Fort Worth Texas

Sponsors (1)
Lead Sponsor Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

References & Publications (1)

Kaback M, Scoper SV, Arzeno G, James JE, Hua SY, Salem C, Dickerson JE, Landry TA, Bergamini MV; Brinzolamide 1%/Timolol 0.5% Study Group.. Intraocular pressure-lowering efficacy of brinzolamide 1%/timolol 0.5% fixed combination compared with brinzolamide — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Mean intra-ocular pressure (IOP)
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