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NCT00652106 Clinical Trial

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

Glaucoma Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00652106
Other study ID # 190342-019T
Secondary ID
Status Completed
Phase Phase 3
First received April 1, 2008
Last updated April 1, 2008
Start date June 2003
Est. completion date March 2004

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 and efficacy of brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution compared with concurrent brimonidine 0.2% and timolol ophthalmic solutions

Recruitment information / eligibility
Status Completed
Enrollment 432
Est. completion date March 2004
Est. primary completion date March 2004
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/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• 0.2% brimonidine/0.5% timolol fixed combination ophthalmic solution
0.2% brimonidine/0.5% timolol fixed combination ophthalmic solution 1 drop instilled in each eye twice daily (morning and evening)
• Concurrent brimonidine 0.2% and Timolol 0.5% ophthalmic solution
Brimonidine 0.2% 1 drop instilled in each eye three times daily (morning, afternoon, and evening) and concurrent timolol 0.5% ophthalmic solution 1 drop instilled in each eye twice daily (morning and evening)
• Brimonidine 0.2% ophthalmic solution
Brimonidine 0.2% ophthalmic solution 1 drop instilled in each eye three times daily (morning, afternoon, and 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 Intraocular pressure (IOP) Day 28 No
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