Safety and Efficacy Study of Different Formulations of Bimatoprost Once-Daily in Patients With Glaucoma or Ocular Hypertension - Full Text View

Purpose

This study evaluates the safety and efficacy of different formulations of bimatoprost ophthalmic solution compared with Bimatoprost 0.03% once-daily in patients with glaucoma or ocular hypertension. One of the test formulations was given to one eye and bimatoprost 0.03% given to the fellow eye of each patient

Condition	Intervention	Phase
Glaucoma Ocular Hypertension	Drug: Bimatoprost 0.01% ophthalmic solution Drug: Bimatoprost 0.015% formulation 1 ophthalmic solution Drug: Bimatoprost 0.015% formulation 2 ophthalmic solution Drug: Bimatoprost 0.02% ophthalmic solution Drug: Bimatoprost 0.03% ophthalmic solution	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment

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 5 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Patient Comfort [ Time Frame: Days 1-4 ] [ Designated as safety issue: No ]
Patient Satisfaction [ Time Frame: Day 5 ] [ Designated as safety issue: No ]
Treatment Preference [ Time Frame: Day 5 ] [ Designated as safety issue: No ]

Enrollment:	249
Study Start Date:	January 2005
Study Completion Date:	May 2005
Primary Completion Date:	May 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Bimatoprost 0.01% ophthalmic solution	Drug: Bimatoprost 0.01% ophthalmic solution One drop in one eye, once daily in the morning for 4 consecutive days, the other eye received the active control eye drop
Experimental: 2 Bimatoprost 0.015% formulation 1 ophthalmic solution	Drug: Bimatoprost 0.015% formulation 1 ophthalmic solution One drop in one eye, once daily in the morning for 4 consecutive days, the other eye received the active control eye drop
Experimental: 3 Bimatoprost 0.015% formulation 2 ophthalmic solution	Drug: Bimatoprost 0.015% formulation 2 ophthalmic solution One drop in one eye, once daily in the morning for 4 consecutive days, the other eye received the active control eye drop
Experimental: 4 Bimatoprost 0.02% ophthalmic solution	Drug: Bimatoprost 0.02% ophthalmic solution One drop in one eye, once daily in the morning for 4 consecutive days, the other eye received the active control eye drop
Active Comparator: 5 Bimatoprost 0.03% ophthalmic solution	Drug: Bimatoprost 0.03% ophthalmic solution Bimatoprost 0.03% ophthalmic solution, one drop in one eye, once daily in the morning for 4 consecutive days, the other eye received one drop of any of the 4 study drugs Other Name: LUMIGAN®

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Ocular hypertension or glaucoma in both eyes
Require IOP-lowering therapy in each eye

Exclusion Criteria:

Uncontrolled systemic disease
Known allergy or hypersensitivity to bimatoprost

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00652496

Locations

United States, Washington

Wenatchee, Washington, United States

Sponsors and Collaborators

Allergan

Investigators

Study Director:

Medical Director

Allergan

More Information

No publications provided

Responsible Party:	Therapeutic Area Head, Allergan, Inc.
ClinicalTrials.gov Identifier:	NCT00652496 History of Changes
Other Study ID Numbers:	192024-030
Study First Received:	April 1, 2008
Last Updated:	April 1, 2008
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Glaucoma
Hypertension
Ocular Hypertension
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Bimatoprost
Cloprostenol
Antihypertensive Agents

Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 17, 2013