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NCT00314171 Clinical Trial

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

Ocular Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00314171
Other study ID # C-05-10
Secondary ID
Status Completed
Phase Phase 3
First received April 10, 2006
Last updated November 17, 2016
Start date October 2005
Est. completion date August 2007

Study information
Verified date March 2012
Source Alcon Research
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationUnited States: Institutional Review Board
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 437
Est. completion date August 2007
Est. primary completion date August 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 18 years or older

- Diagnosis of open-angle glaucoma or ocular hypertension

- 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 in the study eye(s) twice daily for 12 months
• Dorzolamide 20 mg/ml + Timolol 5 mg/ml eye drops, solution (COSOPT)
One drop in the study eye(s) twice daily for 12 months

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Alcon Research

References & Publications (1)

Manni G, Denis P, Chew P, Sharpe ED, Orengo-Nania S, Coote MA, Laganovska G, Volksone L, Zeyen T, Filatori I, James J, Aung T. The safety and efficacy of brinzolamide 1%/timolol 0.5% fixed combination versus dorzolamide 2%/timolol 0.5% in patients with op — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Mean IOP
Secondary Percent patients with IOP < 18 mmHg
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