A Study of the Safety and Efficacy of Bimatoprost in Patients With Glaucoma or Ocular Hypertension

This study has been completed.

First Received: September 28, 2007 Last Updated: September 10, 2008 History of Changes

Sponsored by:	Allergan
Information provided by:	Allergan
ClinicalTrials.gov Identifier:	NCT00538304

Purpose

A one month study which will determine the safety and efficacy of bimatoprost eye drops in patients with glaucoma or ocular hypertension

Condition	Intervention	Phase
Glaucoma Ocular Hypertension	Drug: bimatoprost eye drops Drug: placebo	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study

Resource links provided by NLM:

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Glaucoma High Blood Pressure

Drug Information available for: Bimatoprost

Further study details as provided by Allergan:

Primary Outcome Measures:

Conjunctival hyperemia [ Time Frame: Month 1 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Enrollment:	222
Study Start Date:	November 2007
Study Completion Date:	May 2008
Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: bimatoprost eye drops 1 drop in each eye daily for 1 month
2: Placebo Comparator	Drug: placebo 1 drop in each eye daily for 1 month

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00538304

Locations

United States, Georgia

Atlanta, Georgia, United States

Sponsors and Collaborators

Allergan

Investigators

Study Director:

Medical Director

Allergan

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Allergan, Inc. ( Therapeutic Area Head )
Study ID Numbers:	192024-035
Study First Received:	September 28, 2007
Last Updated:	September 10, 2008
ClinicalTrials.gov Identifier:	NCT00538304 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Bimatoprost
Glaucoma
Eye Diseases
Vascular Diseases
Cardiovascular Agents

Tetrahydrozoline
Antihypertensive Agents
Hypertension
Ocular Hypertension

Additional relevant MeSH terms:

Bimatoprost
Glaucoma
Therapeutic Uses
Eye Diseases
Vascular Diseases
Cardiovascular Diseases

Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions
Ocular Hypertension
Hypertension

ClinicalTrials.gov processed this record on July 02, 2009