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

• Sponsor: Allergan (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00652483
• Collaborator: (none)
• Enrollment: 433
• Location: 1
• Arms: 2
• Duration (Months): 16.1
• Patients Per Site Per Month: 27

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Glaucoma; Ocular Hypertension	Drug: Brimonidine ophthalmic solution 0.1%; Drug: Brimonidine ophthalmic solution 0.2%	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 433 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Study Start Date: May 1, 2003
• Actual Primary Completion Date: Dec 1, 2003
• Actual Study Completion Date: Sep 1, 2004

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Brimonidine ophthalmic solution 0.1%	Drug: Brimonidine ophthalmic solution 0.1%; 1 drop instilled in each eye 3 times daily (08:00, 14:00, 20:00)
Active Comparator: 2 Brimonidine ophthalmic solution 0.2%	Drug: Brimonidine ophthalmic solution 0.2%; 1 drop instilled in each eye 3 times daily (08:00, 14:00, 20:00); Other Names: ALPHAGAN®

Outcome Measures

Primary Outcome Measures

1. Intraocular pressure (IOP) [Week 2 - Month 3]

Secondary Outcome Measures

1. IOP [Month 6 - Month 12]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Ocular hypertension or glaucoma in both eyes

Exclusion Criteria:

• Uncontrolled systemic disease

• Known allergy or sensitivity to brimonidine

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Atlanta	Georgia	United States

Sponsors and Collaborators

• Allergan

Investigators

• Study Director: Medical Director, Allergan

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Link to Clinical Trial Results

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00652483
• Other Study ID Numbers: 190342-021
• First Posted: Apr 3, 2008
• Last Update Posted: Apr 3, 2008
• Last Verified: Apr 1, 2008

• Additional relevant MeSH terms: Glaucoma; Ocular Hypertension; Hypertension; Brimonidine Tartrate; Pharmaceutical Solutions; Ophthalmic Solutions

Study Results

No Results Posted as of Apr 3, 2008