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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00652483
Other study ID # 190342-021
Secondary ID
Status Completed
Phase Phase 3
First received April 1, 2008
Last updated April 1, 2008
Start date May 2003
Est. completion date September 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 0.1% ophthalmic solution compared with brimonidine 0.2% ophthalmic solution in patients with glaucoma or ocular hypertension


Recruitment information / eligibility

Status Completed
Enrollment 433
Est. completion date September 2004
Est. primary completion date December 2003
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Ocular hypertension or glaucoma 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 (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Brimonidine ophthalmic solution 0.1%
1 drop instilled in each eye 3 times daily (08:00, 14:00, 20:00)
Brimonidine ophthalmic solution 0.2%
1 drop instilled in each eye 3 times daily (08:00, 14:00, 20:00)

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) Week 2 - Month 3 No
Secondary IOP Month 6 - Month 12 No
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