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Safety and Efficacy of Bimatoprost Compared With Latanoprost in Patients With Glaucoma or Ocular Hypertension

Primary Purpose

Ocular Hypertension, Glaucoma

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
bimatoprost 0.03% eye drops
latanoprost 0.005% eye drops
Sponsored by
Allergan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ocular Hypertension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Uncontrolled medical conditions
  • Hypersensitivity to study medications

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

bimatoprost 0.03% eye drops

latanoprost 0.005% eye drops

Outcomes

Primary Outcome Measures

Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) at 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.
Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) at 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.

Secondary Outcome Measures

Full Information

First Posted
October 5, 2007
Last Updated
September 19, 2011
Sponsor
Allergan
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1. Study Identification

Unique Protocol Identification Number
NCT00541242
Brief Title
Safety and Efficacy of Bimatoprost Compared With Latanoprost in Patients With Glaucoma or Ocular Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
August 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ocular Hypertension, Glaucoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
586 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
bimatoprost 0.03% eye drops
Arm Title
2
Arm Type
Active Comparator
Arm Description
latanoprost 0.005% eye drops
Intervention Type
Drug
Intervention Name(s)
bimatoprost 0.03% eye drops
Other Intervention Name(s)
latanoprost = Xalatan®, bimatoprost = Lumigan®
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
latanoprost 0.005% eye drops
Other Intervention Name(s)
Xalatan®
Intervention Description
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
Primary Outcome Measure Information:
Title
Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) at Week 12
Description
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.
Time Frame
Baseline, Week 12
Title
Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) at Week 18
Description
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.
Time Frame
Baseline, Week 18

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
City
Newport Beach
State/Province
California
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Safety and Efficacy of Bimatoprost Compared With Latanoprost in Patients With Glaucoma or Ocular Hypertension

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