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

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ClinicalTrials.gov Identifier: NCT00652496
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 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 or disease Intervention/treatment 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  (Clinical Trial)
Actual Enrollment : 249 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : January 2005
Actual Primary Completion Date : May 2005
Actual Study Completion Date : May 2005

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
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®



Primary Outcome Measures :
  1. Intraocular pressure (IOP) [ Time Frame: Day 5 ]

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


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

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

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