A Safety and Efficacy Study of ALPHAGAN® P and LUMIGAN® in Subjects Previously Treated With Latanoprost for Glaucoma and Ocular Hypertension
NCT01525173 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 137
Last updated 2013-12-04
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.
Conditions
Interventions
- DRUG
-
0.1% brimonidine tartrate ophthalmic solution
1 drop of 0.1% brimonidine tartrate ophthalmic solution 3 times per day for 12 weeks.
- DRUG
-
0.01% bimatoprost ophthalmic solution
1 drop of 0.01% bimatoprost ophthalmic solution once per day for 12 weeks.
- DRUG
-
0.2% hypromellose lubricant eye drops
1 drop of 0.2% hypromellose lubricant eye drops 3 times per day for 12 weeks.
- DRUG
-
latanoprost 0.005% ophthalmic solution
1 drop of latanoprost 0.005% ophthalmic solution once daily as run-in therapy for 30 days only.
Sponsors & Collaborators
-
Allergan
lead INDUSTRY
Principal Investigators
-
Medical Director · Allergan
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-01-31
- Primary Completion
- 2012-10-31
- Completion
- 2012-10-31
Countries
- United States
Study Locations
More Related Trials
-
A Study of Lumigan® in Patients With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT)
NCT01632423 ·Status: COMPLETED
-
Observational Study of Lumigan® 0.01% Treatment for Patients With Primary Open Angle Glaucoma or Ocular Hypertension
NCT01489670 ·Status: COMPLETED
-
Safety and Efficacy Study of Bimatoprost, Latanoprost, and Travoprost in Patients With Elevated Intraocular Pressure (IOP) and Open-angle Glaucoma (OAG)
NCT00716742 ·Status: COMPLETED
-
A Study of Lumigan® 0.01% in Patients With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT)
NCT01589510 ·Status: COMPLETED
-
Lumigan® in Patients With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT)
NCT01628588 ·Status: COMPLETED
-
Safety and Efficacy of Three Formulations of AGN-210669 Ophthalmic Solution Compared With Bimatoprost Ophthalmic Solution
NCT01001195 ·Status: COMPLETED ·Phase: PHASE2
-
A Study of LUMIGAN® RC in the Clinical Setting
NCT01833741 ·Status: COMPLETED ·Phase: PHASE4
-
Safety and Efficacy of a New Ophthalmic Formulation of Bimatoprost in Patients With Open Angle Glaucoma and Ocular Hypertension
NCT01157364 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Efficacy and Safety Study of Bimatoprost 0.01% Alone Compared With Travoprost 0.004% and Timolol 0.5% in Subjects With Glaucoma or Ocular Hypertension
NCT02097719 ·Status: COMPLETED ·Phase: PHASE4
-
Safety and Efficacy of Bimatoprost Compared With Latanoprost in Patients With Glaucoma or Ocular Hypertension
NCT00541242 ·Status: COMPLETED ·Phase: PHASE4
-
Comparing Safety and Efficacy of Combigan® and Lumigan® With Lumigan® Alone in Glaucoma or Ocular Hypertension Subjects Treated With Xalatan®
NCT01170884 ·Status: COMPLETED ·Phase: PHASE4
-
24-hour IOP-lowering Effect of Brimonidine 0.1%
NCT00457795 ·Status: COMPLETED ·Phase: PHASE4
-
Ocular Surface Tolerability Study of Prostaglandin Analogues in Patients With Open-Angle Glaucoma or Ocular Hypertension
NCT01253902 ·Status: COMPLETED ·Phase: PHASE4
-
Safety and Efficacy of LUMIGAN® RC Versus DuoTrav® in Patients Who Require Further Intraocular Pressure (IOP) Reduction
NCT01547598 ·Status: COMPLETED ·Phase: PHASE4
-
Safety and Efficacy of AGN-210669 Ophthalmic Solution Compared With Bimatoprost Ophthalmic Solution in Patients With Open-Angle Glaucoma or Ocular Hypertension
NCT01291108 ·Status: COMPLETED ·Phase: PHASE2
-
Comparison of Different Drugs on Ocular Surface Disease in Glaucoma Patients: a Prospective Randomised Study
NCT04896125 ·Status: UNKNOWN
-
Efficacy and Safety of Bimatoprost Sustained-Release (SR) in Patients With Open-Angle Glaucoma or Ocular Hypertension
NCT02250651 ·Status: COMPLETED ·Phase: PHASE3
-
A Safety and Efficacy Study of Bimatoprost 0.01% in Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH)
NCT01594970 ·Status: COMPLETED ·Phase: PHASE4
-
A Study of Patients With Primary Open Angle Glaucoma or Ocular Hypertension Switched to Lumigan® UD Monotherapy for Medical Reasons
NCT01853085 ·Status: COMPLETED
-
Comparison of Latanoprost With Travoprost and Bimatoprost in Patients With Elevated IOP. A 12-weeks, Masked Evaluator, Phase IV Multi-center Study in the US
NCT00847483 ·Status: COMPLETED ·Phase: PHASE4
-
Efficacy and Safety Study of Bimatoprost Sustained-Release (SR) in Participants With Open-angle Glaucoma or Ocular Hypertension
NCT02247804 ·Status: COMPLETED ·Phase: PHASE3
-
A Safety Study of Bimatoprost in Patients With Glaucoma or Ocular Hypertension
NCT01830140 ·Status: COMPLETED ·Phase: PHASE3
-
An Efficacy and Safety Study of Bimatoprost 0.01% Alone Compared With Travoprost 0.004% and Timolol 0.5% in Subjects With Glaucoma or Ocular Hypertension
NCT01881126 ·Status: COMPLETED ·Phase: PHASE4
-
A Phase 3b Study Evaluating the 24-Hour Intraocular Pressure Lowering Effect of Bimatoprost SR in Patients With Open-Angle Glaucoma or Ocular Hypertension
NCT04285580 ·Status: COMPLETED ·Phase: PHASE3
-
Safety and Efficacy of Bimatoprost/Timolol Fixed Combination Versus Latanoprost in Patients With Open-Angle Glaucoma Who Have Never Been Treated
NCT01243567 ·Status: COMPLETED ·Phase: PHASE4