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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

541 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-08-31

Study Completion Date

2003-08-31

Brief Summary

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The purpose of this study is to assess the safety and efficacy of Bimatoprost/Timolol Fixed Combination in the treatment of glaucoma or ocular hypertension

Detailed Description

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Conditions

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Ocular Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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bimatoprost/timolol fixed combination

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of ocular hypertension or chronic glaucoma in both eyes
* Patient needs IOP-lowering drug in both eyes

Exclusion Criteria

* Uncontrolled medical condition
* Contraindication to beta-adrenoceptor antagonist therapy

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Allergan, Inc

Locations

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Ogden, Utah, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED

PMID: 19855289 (View on PubMed)

Other Identifiers

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192024-021T

Identifier Type: -

Identifier Source: org_study_id