Back to resultsSafety and Efficacy of Different Formulations of Bimatoprost Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension
Primary Purpose
Glaucoma, Ocular Hypertension
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Bimatoprost 0.03% Formulation B Ophthalmic Solution
Bimatoprost 0.03% Ophthalmic Solution
Sponsored by
About this trial
This is an interventional treatment trial for Glaucoma
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Bimatoprost 0.03% Formulation B Ophthalmic Solution
Bimatoprost 0.03% Ophthalmic Solution
Arm Description
Bimatoprost 0.03% Formulation B Ophthalmic Solution
Bimatoprost 0.03% Ophthalmic Solution
Outcomes
Primary Outcome Measures
Change From Baseline in Worse Eye Intraocular Pressure (IOP) at 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.
Average Eye IOP at 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.
Average Eye IOP at 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.
Average Eye IOP at 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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01099774
Brief Title
Safety and Efficacy of Different Formulations of Bimatoprost Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
May 1, 2010 (Actual)
Primary Completion Date
April 29, 2011 (Actual)
Study Completion Date
April 29, 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Ocular Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
597 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bimatoprost 0.03% Formulation B Ophthalmic Solution
Arm Type
Experimental
Arm Description
Bimatoprost 0.03% Formulation B Ophthalmic Solution
Arm Title
Bimatoprost 0.03% Ophthalmic Solution
Arm Type
Active Comparator
Arm Description
Bimatoprost 0.03% Ophthalmic Solution
Intervention Type
Drug
Intervention Name(s)
Bimatoprost 0.03% Formulation B Ophthalmic Solution
Intervention Description
One drop administered in each eye, every evening, for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Bimatoprost 0.03% Ophthalmic Solution
Other Intervention Name(s)
LUMIGAN®
Intervention Description
One drop administered in each eye, every evening, for 12 weeks
Primary Outcome Measure Information:
Title
Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Week 12
Description
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.
Time Frame
Baseline, Week 12
Title
Average Eye IOP at Week 12
Description
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.
Time Frame
Baseline, Week 12
Title
Average Eye IOP at Week 6
Description
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.
Time Frame
Week 6
Title
Average Eye IOP at Week 2
Description
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.
Time Frame
Week 2
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
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
Citations:
PubMed Identifier
23743437
Citation
Day DG, Walters TR, Schwartz GF, Mundorf TK, Liu C, Schiffman RM, Bejanian M. Bimatoprost 0.03% preservative-free ophthalmic solution versus bimatoprost 0.03% ophthalmic solution (Lumigan) for glaucoma or ocular hypertension: a 12-week, randomised, double-masked trial. Br J Ophthalmol. 2013 Aug;97(8):989-93. doi: 10.1136/bjophthalmol-2012-303040. Epub 2013 Jun 6.
Results Reference
background
Learn more about this trial
Safety and Efficacy of Different Formulations of Bimatoprost Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension
We'll reach out to this number within 24 hrs