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Safety and Efficacy of Different Formulations of Bimatoprost Ophthalmic Solution 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: NCT01099774
Recruitment Status : Completed
First Posted : April 8, 2010
Results First Posted : April 27, 2012
Last Update Posted : April 17, 2019
Sponsor:
Information provided by (Responsible Party):
Allergan

Brief Summary:
This study will evaluate the safety and efficacy of bimatoprost 0.03% formulation B ophthalmic solution with LUMIGAN® (bimatoprost ophthalmic solution 0.03%) once daily for 12 weeks in patients with glaucoma or ocular hypertension

Condition or disease Intervention/treatment Phase
Glaucoma Ocular Hypertension Drug: Bimatoprost 0.03% Formulation B Ophthalmic Solution Drug: Bimatoprost 0.03% Ophthalmic Solution Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 597 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Actual Study Start Date : May 1, 2010
Actual Primary Completion Date : April 29, 2011
Actual Study Completion Date : April 29, 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma
Drug Information available for: Bimatoprost

Arm Intervention/treatment
Experimental: Bimatoprost 0.03% Formulation B Ophthalmic Solution
Bimatoprost 0.03% Formulation B Ophthalmic Solution
Drug: Bimatoprost 0.03% Formulation B Ophthalmic Solution
One drop administered in each eye, every evening, for 12 weeks

Active Comparator: Bimatoprost 0.03% Ophthalmic Solution
Bimatoprost 0.03% Ophthalmic Solution
Drug: Bimatoprost 0.03% Ophthalmic Solution
One drop administered in each eye, every evening, for 12 weeks
Other Name: LUMIGAN®




Primary Outcome Measures :
  1. Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Week 12 [ Time Frame: Baseline, Week 12 ]
    Change from baseline in worse eye IOP at Week 12 . IOP is a measurement of fluid pressure inside the eye. IOP measurements in the worse eye were evaluated at hours 0, 2, and 8. A negative number change from baseline indicated a reduction in IOP, and a positive number change from baseline indicated an increase in IOP.

  2. Average Eye IOP at Week 12 [ Time Frame: Baseline, Week 12 ]
    Average Eye IOP at Week 12 . IOP is a measurement of fluid pressure inside the eye. IOP measurements were evaluated at hours 0, 2, and 8 in both eyes and the average IOP of both eyes at each time point were reported. Baseline data are included for reference only.

  3. Average Eye IOP at Week 6 [ Time Frame: Week 6 ]
    Average Eye IOP at Week 6 . IOP is a measurement of fluid pressure inside the eye. IOP measurements were evaluated at hours 0, 2, and 8 in both eyes and the average IOP of both eyes at each time point were reported.

  4. Average Eye IOP at Week 2 [ Time Frame: Week 2 ]
    Average Eye IOP at Week 2 . IOP is a measurement of fluid pressure inside the eye. IOP measurements were evaluated at hours 0, 2, and 8 in both eyes and the average IOP of both eyes at each time point were reported.



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:

  • Patient has ocular hypertension or glaucoma in both eyes
  • Requires IOP-lowering therapy in each eye

Exclusion Criteria:

  • Active or recurrent eye disease that would interfere with interpretation of study data in either eye
  • History of any eye surgery or laser in either eye within 6 months
  • Required chronic use of other eye medications during the study
  • Anticipated wearing of contact lenses during the study.
  • Intermittent use of oral, intramuscular, or intravenous corticosteroids within 21 days

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): NCT01099774


Locations
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United States, California
Newport Beach, California, United States
Sponsors and Collaborators
Allergan
Investigators
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Study Director: Medical Director Allergan
Publications:
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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01099774    
Other Study ID Numbers: 192024-048
First Posted: April 8, 2010    Key Record Dates
Results First Posted: April 27, 2012
Last Update Posted: April 17, 2019
Last Verified: April 2019
Additional relevant MeSH terms:
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Glaucoma
Ocular Hypertension
Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Bimatoprost
Ophthalmic Solutions
Pharmaceutical Solutions
Antihypertensive Agents