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

Primary Purpose

Ocular Hypertension

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
brimonidine/timolol fixed combination
Sponsored by
Allergan
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ocular Hypertension

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Clinical diagnosis of glaucoma or ocular hypertension in both eyes Patient requires IOP-lowering in both eyes Exclusion Criteria: Uncontrolled medical conditions Contraindication to beta-andrenoceptor antagonist or brimonidine therapy

Sites / Locations

Outcomes

Primary Outcome Measures

IOP

Secondary Outcome Measures

Full Information

First Posted
May 30, 2006
Last Updated
May 27, 2011
Sponsor
Allergan
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1. Study Identification

Unique Protocol Identification Number
NCT00332345
Brief Title
Safety and Efficacy Study of Brimonidine/Timolol Fixed Combination in Patients With Glaucoma or Ocular Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
July 1999 (undefined)
Primary Completion Date
August 1999 (Actual)
Study Completion Date
August 1999 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Allergan

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to assess the safety and efficacy of Brimonidine/Timolol Fixed Combination in patients with glaucoma or ocular hypertension

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ocular Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
73 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
brimonidine/timolol fixed combination
Primary Outcome Measure Information:
Title
IOP

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis of glaucoma or ocular hypertension in both eyes Patient requires IOP-lowering in both eyes Exclusion Criteria: Uncontrolled medical conditions Contraindication to beta-andrenoceptor antagonist or brimonidine therapy
Facility Information:
City
Artesia
State/Province
California
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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