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Safety and Efficacy of Bimatoprost Compared With Latanoprost 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: NCT00541242
Recruitment Status : Completed
First Posted : October 10, 2007
Results First Posted : October 27, 2011
Last Update Posted : October 27, 2011
Sponsor:
Information provided by (Responsible Party):
Allergan

Brief Summary:
The study will compare the safety and efficacy of Bimatoprost and Latanoprost in patients with glaucoma or ocular hypertension

Condition or disease Intervention/treatment Phase
Ocular Hypertension Glaucoma Drug: bimatoprost 0.03% eye drops Drug: latanoprost 0.005% eye drops Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 586 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : December 2007
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arm Intervention/treatment
Active Comparator: 1
bimatoprost 0.03% eye drops
Drug: bimatoprost 0.03% eye drops
Open-labeled latanoprost 0.005% 1 drop into each eye every evening for 6 weeks followed by a masked randomized treatment of bimatoprost 0.03% 1 drop every evening for 12 weeks
Other Names:
  • latanoprost = Xalatan®
  • bimatoprost = Lumigan®

Active Comparator: 2
latanoprost 0.005% eye drops
Drug: latanoprost 0.005% eye drops
Open-labeled latanoprost 0.005% 1 drop into each eye every evening for 6 weeks followed by a masked randomized treatment of latanoprost 0.005% 1 drop every evening for 12 weeks
Other Name: Xalatan®




Primary Outcome Measures :
  1. Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) at Week 12 [ Time Frame: Baseline, Week 12 ]
    Change from Baseline in mean diurnal IOP. IOP is a measurement of the fluid pressure inside the eye. Mean diurnal IOP is the average of the IOP values of both eyes at each time point measured at 8AM, 12PM and 4PM. For each eye, the IOP was either the average of the 2 measurements, or, if a third measurement was required, the median of the 3 measurements. A negative number change from Baseline indicated a reduction in IOP.

  2. Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) at Week 18 [ Time Frame: Baseline, Week 18 ]
    Change from Baseline in mean diurnal IOP. IOP is a measurement of the fluid pressure inside the eye. Mean diurnal IOP is the average of the IOP values of both eyes at each time point measured at 8AM, 12PM and 4PM. For each eye, the IOP was either the average of the 2 measurements, or, if a third measurement was required, the median of the 3 measurements. A negative number change from Baseline indicated a reduction in IOP.



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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 chronic glaucoma
  • Patient requires IOP-lowering therapy in both eyes

Exclusion Criteria:

  • Uncontrolled medical conditions
  • Hypersensitivity to study medications

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): NCT00541242


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
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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT00541242    
Other Study ID Numbers: 192024-034
First Posted: October 10, 2007    Key Record Dates
Results First Posted: October 27, 2011
Last Update Posted: October 27, 2011
Last Verified: September 2011
Additional relevant MeSH terms:
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Glaucoma
Ocular Hypertension
Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Latanoprost
Bimatoprost
Ophthalmic Solutions
Pharmaceutical Solutions
Antihypertensive Agents