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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:
ClinicalTrials.gov Identifier:
NCT00651859
First Posted: April 3, 2008
Last Update Posted: April 3, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Allergan
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • Intraocular pressure (IOP) [ Time Frame: Day 14 ]

Secondary Outcome Measures:
  • IOP [ Time Frame: Days 2 and 7 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00651859


Locations
United States, California
San Francisco, California, United States
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

Additional Information:
Responsible Party: Therapeutic Area Head, Allergan, Inc.
ClinicalTrials.gov Identifier: NCT00651859     History of Changes
Other Study ID Numbers: 192024-024
First Submitted: April 1, 2008
First Posted: April 3, 2008
Last Update Posted: April 3, 2008
Last Verified: April 2008

Additional relevant MeSH terms:
Hypertension
Glaucoma
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Pharmaceutical Solutions
Ophthalmic Solutions
Bimatoprost
Antihypertensive Agents