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

Primary Purpose

Ocular Hypertension

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
bimatoprost/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

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

Inclusion Criteria: Clinical diagnosis of ocular hypertension or chronic glaucoma in both eyes Patient requires IOP-lowering drug in both eyes Exclusion Criteria: Uncontrolled medical condition Contraindication to beta-adrenoceptor antagonist 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
NCT00332540
Brief Title
Safety and Efficacy Study of Bimatoprost/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
August 2001 (undefined)
Primary Completion Date
August 2003 (Actual)
Study Completion Date
August 2003 (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 Bimatoprost/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 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
520 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis of ocular hypertension or chronic glaucoma in both eyes Patient requires IOP-lowering drug in both eyes Exclusion Criteria: Uncontrolled medical condition Contraindication to beta-adrenoceptor antagonist therapy
Facility Information:
City
Rochester
State/Province
New York
Country
United States
City
Sherbrooke
State/Province
Quebec
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
19855289
Citation
Lewis RA, Gross RL, Sall KN, Schiffman RM, Liu CC, Batoosingh AL; Ganfort Investigators Group II. The safety and efficacy of bimatoprost/timolol fixed combination: a 1-year double-masked, randomized parallel comparison to its individual components in patients with glaucoma or ocular hypertension. J Glaucoma. 2010 Aug;19(6):424-6. doi: 10.1097/IJG.0b013e3181bdb586. No abstract available. Erratum In: J Glaucoma. 2014 Dec;23(9):663.
Results Reference
derived

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

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