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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00652496
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 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
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 5 ]

Secondary Outcome Measures:
  • Patient Comfort [ Time Frame: Days 1-4 ]
  • Patient Satisfaction [ Time Frame: Day 5 ]
  • Treatment Preference [ Time Frame: Day 5 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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): NCT00652496


Locations
United States, Washington
Wenatchee, Washington, United States
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

Responsible Party: Therapeutic Area Head, Allergan, Inc.
ClinicalTrials.gov Identifier: NCT00652496     History of Changes
Other Study ID Numbers: 192024-030
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