Safety and Efficacy Study of Bimatoprost in Ethnically Japanese Patients With Open-Angle Glaucoma or Ocular Hypertension - Full Text View

Sponsored by:	Allergan
Information provided by:	Allergan
ClinicalTrials.gov Identifier:	NCT00651859

Purpose

This study evaluates the safety and efficacy of once-daily bimatoprost 0.03% and 0.01% ophthalmic solutions compared with once-daily administered bimatoprost vehicle ophthalmic solution for 2 weeks in ethnically Japanese patients with open-angle glaucoma or ocular hypertension

Condition	Intervention	Phase
Glaucoma Ocular Hypertension	Drug: Bimatoprost 0.01% Ophthalmic Solution Drug: Bimatoprost 0.03% Ophthalmic Solution Drug: Bimatoprost Vehicle Ophthalmic Solution	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), 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

U.S. FDA Resources

Further study details as provided by Allergan:

Primary Outcome Measures:

Intraocular pressure (IOP) [ Time Frame: Day 14 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

IOP [ Time Frame: Days 2 and 7 ] [ Designated as safety issue: No ]

Enrollment:	111
Study Start Date:	November 2002
Study Completion Date:	January 2004
Primary Completion Date:	January 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Bimatoprost 0.01% Ophthalmic Solution	Drug: Bimatoprost 0.01% Ophthalmic Solution Bimatoprost 0.01% ophthalmic solution 1 drop instilled in each eye once daily in the evening between 19:00 and 21:00
2: Experimental Bimatoprost 0.03% Ophthalmic Solution	Drug: Bimatoprost 0.03% Ophthalmic Solution Bimatoprost 0.03% ophthalmic solution 1 drop instilled in each eye once daily in the evening between 19:00 and 21:00
3: Placebo Comparator Bimatoprost Vehicle Ophthalmic Solution	Drug: Bimatoprost Vehicle Ophthalmic Solution Bimatoprost vehicle ophthalmic solution 1 drop instilled in each eye once daily in the evening between 19:00 and 21:00

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Ethnically Japanese patients with glaucoma or ocular hypertension in each eye who require IOP-lowering therapy in both eyes

Exclusion Criteria:

Uncontrolled systemic disease
Use of bimatoprost or an ocular prostaglandin (eg, latanoprost, travoprost) within 6 weeks prior to baseline (Day 0)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00651859

Locations

United States, California

San Francisco, California, United States

Sponsors and Collaborators

Allergan

Investigators

Study Director:

Medical Director

Allergan

More Information

Additional Information:

Link to Clinical Trial Results This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Allergan, Inc. ( Therapeutic Area Head )
Study ID Numbers:	192024-024
Study First Received:	April 1, 2008
Last Updated:	April 1, 2008
ClinicalTrials.gov Identifier:	NCT00651859 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Bimatoprost
Contraceptive Agents
Glaucoma
Eye Diseases
Glaucoma, Open-Angle
Contraceptive Agents, Female

Vascular Diseases
Cardiovascular Agents
Antihypertensive Agents
Cloprostenol
Hypertension
Ocular Hypertension

Additional relevant MeSH terms:

Bimatoprost
Contraceptive Agents
Eye Diseases
Physiological Effects of Drugs
Contraceptive Agents, Female
Vascular Diseases
Reproductive Control Agents
Cardiovascular Agents
Antihypertensive Agents

Luteolytic Agents
Cloprostenol
Pharmacologic Actions
Glaucoma
Therapeutic Uses
Cardiovascular Diseases
Hypertension
Ocular Hypertension

ClinicalTrials.gov processed this record on September 11, 2009