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NCT00651612 Clinical Trial

Study to Evaluate Safety of Brimonidine/Timolol Fixed Combination in Glaucoma or Ocular Hypertension Patients

Glaucoma Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00651612
Other study ID # 190342-024T
Secondary ID
Status Completed
Phase Phase 3
First received April 1, 2008
Last updated April 1, 2008
Start date November 2005
Est. completion date January 2007

Study information
Verified date April 2008
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 evaluates the safety of brimonidine/timolol fixed combination in glaucoma or ocular hypertension patients

Recruitment information / eligibility
Status Completed
Enrollment 604
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:

- Diagnosis of ocular hypertension or glaucoma

- Patient requires IOP-lowering therapy in both eyes

Exclusion Criteria:

- Uncontrolled medical conditions

- Contraindication to ß-adrenoceptor antagonist therapy or brimonidine therapy

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• Brimonidine 0.2%/Timolol 0.5% Fixed Combination Ophthalmic Solution
Brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution 1 drop instilled in each eye two times daily (morning and evening)
• Concurrent brimonidine 0.2% and 0.5% timolol
Brimonidine 0.2%, 1 drop instilled in each eye three times daily (morning, afternoon, and evening) and timolol 0.5% timolol, 1 drop instilled in each eye twice daily (morning and evening) and vehicle of brimonidine combination ophthalmic solution 1 drop instilled in each eye (morning, afternoon and/or evening)

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 Adverse Events Day 10 No
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