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

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.
 
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

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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: Glaucoma
Drug Information available for: Bimatoprost

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, Older Adult)
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
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United States, Washington
Wenatchee, Washington, United States
Sponsors and Collaborators
Allergan
Investigators
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Study Director: Medical Director Allergan
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Responsible Party: Therapeutic Area Head, Allergan, Inc.
ClinicalTrials.gov Identifier: NCT00652496    
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:
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Glaucoma
Ocular Hypertension
Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Bimatoprost
Pharmaceutical Solutions
Ophthalmic Solutions
Antihypertensive Agents