A Study of the Safety and Efficacy of Bimatoprost in Patients With Glaucoma or Ocular Hypertension - Full Text View

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

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Glaucoma High Blood Pressure

Drug Information available for: Tetrahydrozoline Tetrahydrozoline hydrochloride Bimatoprost

U.S. FDA Resources

Study Type:

Interventional

Study Design:

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

Further study details as provided by Allergan:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

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

Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Chronic glaucoma or ocular hypertension
IOP controlled on Xalatan

Exclusion Criteria:

Uncontrolled medical conditions
Known hypersensitivity to study medications

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

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:

Allergan, Inc. ( Therapeutic Area Head )

Study ID Numbers:

192024-035

First Received:

September 28, 2007

Last Updated:

September 10, 2008

ClinicalTrials.gov Identifier:

NCT00538304

Health Authority:

United States: Food and Drug Administration

Study placed in the following topic categories:

Bimatoprost
Glaucoma
Eye Diseases
Vascular Diseases

Tetrahydrozoline
Hypertension
Ocular Hypertension

Additional relevant MeSH terms:

Therapeutic Uses
Cardiovascular Diseases
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 07, 2009