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NCT00168363 Clinical Trial

Safety and Efficacy of Brimonidine in Patients With Glaucoma or Ocular Hypertension

Glaucoma Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00168363
Other study ID # 190342-022
Secondary ID
Status Completed
Phase Phase 3
First received September 12, 2005
Last updated May 27, 2011
Start date January 2005
Est. completion date August 2006

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

This Study will evaluate the safety and efficacy of brimonidine in patients with glaucoma or ocular hypertension

Recruitment information / eligibility
Status Completed
Enrollment 207
Est. completion date August 2006
Est. primary completion date August 2006
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- ocular hypertension or glaucoma in both eyes

- currently treated with brimonidine

- requires IOP-lowering therapy in both eyes

Exclusion Criteria:

- uncontrolled systemic disease

- known allergy or sensitivity to brimonidine

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

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Allergan

Outcome
Type Measure Description Time frame Safety issue
Primary lowering of intraocular pressure
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