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NCT00332384 Clinical Trial

Safety and Efficacy Study of Brimonidine/Timolol Fixed Combination in Patients With Glaucoma or Ocular Hypertension

Ocular Hypertension Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00332384
Other study ID # 190342-012T
Secondary ID
Status Completed
Phase Phase 3
First received May 30, 2006
Last updated May 27, 2011
Start date January 2000
Est. completion date November 2001

Study information
Verified date May 2011
Source Allergan
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 assess the safety and efficacy of Brimonidine/Timolol Fixed Combination in patients with glaucoma or ocular hypertension

Recruitment information / eligibility
Status Completed
Enrollment 573
Est. completion date November 2001
Est. primary completion date November 2001
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Clinical diagnosis of ocular hypertension or chronic glaucoma in both eyes

- Patient requires IOP-lowering drug in both eyes

Exclusion Criteria:

- Uncontrolled medical conditions

- contraindication to beta-adrenoceptor antagonist or brimonidine therapy

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• brimonidine/timolol fixed combination

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Allergan

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary IOP
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