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

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ClinicalTrials.gov Identifier: NCT00651859
Recruitment Status : Completed
First Posted : April 3, 2008
Last Update Posted : April 3, 2008
Sponsor:
Information provided by:
Allergan

Brief Summary:
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 or disease Intervention/treatment 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  (Clinical Trial)
Actual Enrollment : 111 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : November 2002
Primary Completion Date : January 2004
Study Completion Date : January 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Care Glaucoma
Drug Information available for: Bimatoprost
U.S. FDA Resources

Arm Intervention/treatment
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



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

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


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)

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

Additional Information:
Responsible Party: Therapeutic Area Head, Allergan, Inc.
ClinicalTrials.gov Identifier: NCT00651859     History of Changes
Other Study ID Numbers: 192024-024
First Posted: April 3, 2008    Key Record Dates
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