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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:
Information provided by:
Allergan
ClinicalTrials.gov Identifier:
NCT00652496
First received: April 1, 2008
Last updated: NA
Last verified: April 2008
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient Comfort [ Time Frame: Days 1-4 ] [ Designated as safety issue: No ]
  • Patient Satisfaction [ Time Frame: Day 5 ] [ Designated as safety issue: No ]
  • Treatment Preference [ Time Frame: Day 5 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00652496

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

No publications provided

Responsible Party: Therapeutic Area Head, Allergan, Inc.
ClinicalTrials.gov Identifier: NCT00652496     History of Changes
Other Study ID Numbers: 192024-030
Study First Received: April 1, 2008
Last Updated: April 1, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Glaucoma
Hypertension
Ocular Hypertension
Cardiovascular Diseases
Eye Diseases
Vascular Diseases
Bimatoprost
Cloprostenol
Ophthalmic Solutions
Pharmaceutical Solutions
Antihypertensive Agents
Cardiovascular Agents
Contraceptive Agents
Contraceptive Agents, Female
Luteolytic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014