Back to resultsA Safety and Efficacy Study of ALPHAGAN® P and LUMIGAN® in Subjects Previously Treated With Latanoprost for Glaucoma and Ocular Hypertension
Primary Purpose
Glaucoma, Ocular Hypertension
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
0.1% brimonidine tartrate ophthalmic solution
0.01% bimatoprost ophthalmic solution
0.2% hypromellose lubricant eye drops
latanoprost 0.005% ophthalmic solution
Sponsored by
About this trial
This is an interventional treatment trial for Glaucoma
Eligibility Criteria
Inclusion Criteria:
- Ocular hypertension or glaucoma in at least 1 eye
- Visual acuity of 20/100 or better in both eyes
Exclusion Criteria:
- Corneal refractive laser surgery (LASIK, LASEK, PRK, RK) in the study eye(s)
- Intraocular or glaucoma surgery in the past 3 months
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
ALPHAGAN® P and LUMIGAN®
LUMIGAN® Alone
Arm Description
1 drop of latanoprost 0.005% ophthalmic solution once daily in each eye as run-in therapy for 30 days followed by 1 drop of 0.1% brimonidine tartrate ophthalmic solution (ALPHAGAN® P) 3 times per day and 1 drop of 0.01% bimatoprost ophthalmic solution (LUMIGAN®) once per day for 12 weeks.
1 drop of latanoprost 0.005% ophthalmic solution once daily in each eye as run-in therapy for 30 days followed by 1 drop of 0.2% hypromellose lubricant eye drops (used for masking purposes) 3 times per day and 1 drop of 0.01% bimatoprost ophthalmic solution (LUMIGAN®) once per day for 12 weeks.
Outcomes
Primary Outcome Measures
Change From Baseline in Mean Diurnal Intraocular Pressure (IOP)
IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the study eye, defined as the worse eye at Baseline. The mean diurnal IOP is the average of all the IOP measurements in the study eye taken at 8 AM, 10 AM and 4 PM at Baseline and at Week 12. A negative change from Baseline indicated improvement.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01525173
Brief Title
A Safety and Efficacy Study of ALPHAGAN® P and LUMIGAN® in Subjects Previously Treated With Latanoprost for Glaucoma and Ocular Hypertension
Study Type
Interventional
2. Study Status
Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (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 efficacy and safety of either bimatoprost 0.01% ophthalmic solution (Lumigan®) alone or bimatoprost 0.01% ophthalmic solution (Lumigan®) and brimonidine tartrate 0.1% ophthalmic solution (Alphagan® P) in combination in patients previously treated with latanoprost 0.005% ophthalmic solution monotherapy who require additional intraocular pressure (IOP) lowering medication.
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 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
137 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ALPHAGAN® P and LUMIGAN®
Arm Type
Active Comparator
Arm Description
1 drop of latanoprost 0.005% ophthalmic solution once daily in each eye as run-in therapy for 30 days followed by 1 drop of 0.1% brimonidine tartrate ophthalmic solution (ALPHAGAN® P) 3 times per day and 1 drop of 0.01% bimatoprost ophthalmic solution (LUMIGAN®) once per day for 12 weeks.
Arm Title
LUMIGAN® Alone
Arm Type
Active Comparator
Arm Description
1 drop of latanoprost 0.005% ophthalmic solution once daily in each eye as run-in therapy for 30 days followed by 1 drop of 0.2% hypromellose lubricant eye drops (used for masking purposes) 3 times per day and 1 drop of 0.01% bimatoprost ophthalmic solution (LUMIGAN®) once per day for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
0.1% brimonidine tartrate ophthalmic solution
Other Intervention Name(s)
ALPHAGAN® P
Intervention Description
1 drop of 0.1% brimonidine tartrate ophthalmic solution 3 times per day for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
0.01% bimatoprost ophthalmic solution
Other Intervention Name(s)
LUMIGAN®
Intervention Description
1 drop of 0.01% bimatoprost ophthalmic solution once per day for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
0.2% hypromellose lubricant eye drops
Other Intervention Name(s)
GenTeal ®
Intervention Description
1 drop of 0.2% hypromellose lubricant eye drops 3 times per day for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
latanoprost 0.005% ophthalmic solution
Intervention Description
1 drop of latanoprost 0.005% ophthalmic solution once daily as run-in therapy for 30 days only.
Primary Outcome Measure Information:
Title
Change From Baseline in Mean Diurnal Intraocular Pressure (IOP)
Description
IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the study eye, defined as the worse eye at Baseline. The mean diurnal IOP is the average of all the IOP measurements in the study eye taken at 8 AM, 10 AM and 4 PM at Baseline and at Week 12. A negative change from Baseline indicated improvement.
Time Frame
Baseline, Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Ocular hypertension or glaucoma in at least 1 eye
Visual acuity of 20/100 or better in both eyes
Exclusion Criteria:
Corneal refractive laser surgery (LASIK, LASEK, PRK, RK) in the study eye(s)
Intraocular or glaucoma surgery in the past 3 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
City
Deerfield Beach
State/Province
Florida
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Safety and Efficacy Study of ALPHAGAN® P and LUMIGAN® in Subjects Previously Treated With Latanoprost for Glaucoma and Ocular Hypertension
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