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

This study has been completed.
Sponsor:
Information provided by:
Allergan
ClinicalTrials.gov Identifier:
NCT00651859
First received: April 1, 2008
Last updated: NA
Last verified: April 2008
History: No changes posted
  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 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:

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
Experimental: 1
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
Experimental: 2
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
Other Name: LUMIGAN®
Placebo Comparator: 3
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: Therapeutic Area Head, Allergan, Inc.
ClinicalTrials.gov Identifier: NCT00651859     History of Changes
Other Study ID Numbers: 192024-024
Study First Received: April 1, 2008
Last Updated: April 1, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
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 May 19, 2013