Safety and Efficacy of LUMIGAN® RC Versus DuoTrav® in Patients Who Require Further Intraocular Pressure (IOP) Reduction

Study Overview
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Brief Summary
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This non-inferiority study will assess safety and efficacy of LUMIGAN® RC (bimatoprost ophthalmic solution 0.01%) versus DuoTrav® (travoprost 0.004%/timolol 0.5% combination ophthalmic solution) in patients previously on Travatan® Z (travoprost ophthalmic solution 0.004%) monotherapy.

Conditions
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Glaucoma, Open-Angle, Ocular Hypertension

Intervention / Treatment
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* Drug: travoprost ophthalmic solution 0.004%
* Drug: travoprost 0.004% / timolol 0.5% combination ophthalmic solution
* Drug: Bimatoprost ophthalmic solution 0.01%


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Open angle glaucoma or ocular hypertension Best corrected visual acuity of 20/100 or better in both eyes Exclusion Criteria: Ocular surgery within 3 months, or anticipated ocular surgery within 12 weeks Previous treatment with LUMIGAN® RC or DuoTrav® History of LASIK, LASEK, RK or PRK in the study eye(s) Active ocular inflammation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: LUMIGAN® RC<br>Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, LUMIGAN® RC (bimatoprost ophthalmic solution 0.01%) administered as 1 drop in the affected eye(s) once daily in the evening for 12 weeks. | Drug: travoprost ophthalmic solution 0.004%<br>* Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks.<br>* Other names: Travatan® Z;Drug: Bimatoprost ophthalmic solution 0.01%<br>* LUMIGAN® RC (bimatoprost ophthalmic solution 0.01%) administered as 1 drop in the affected eye(s) once daily in the evening for 12 weeks.<br>* Other names: LUMIGAN® RC;|
| Active Comparator: DuoTrav®<br>Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, DuoTrav® (travoprost 0.004% / timolol 0.5% combination ophthalmic solution) administered as 1 drop in the affected eye(s) once daily in the morning for 12 weeks. | Drug: travoprost ophthalmic solution 0.004%<br>* Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks.<br>* Other names: Travatan® Z;Drug: travoprost 0.004% / timolol 0.5% combination ophthalmic solution<br>* DuoTrav® (travoprost 0.004% / timolol 0.5% combination ophthalmic solution) administered as 1 drop in the affected eye(s) once daily in the morning for 12 weeks.<br>* Other names: DuoTrav®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Diurnal Intraocular Pressure (IOP) | IOP is a measurement of the fluid pressure inside the eye. The mean diurnal IOP was the average of the IOP values of the study eye (worse eye) at Week 12 measured at 8 AM, 12 Noon and 4 PM. For each study eye, IOP was either the average of 2 measurements, or, if a third measurement was required, the average of 3 measurements. | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Mean IOP at Week 12 | IOP is a measurement of the fluid pressure inside the eye. IOP of the study eye (worse eye) was measured at 8 AM, 12 Noon and 4 PM at Week 12. For each eye, IOP was either the average of 2 measurements, or, if a third measurement was required, the average of 3 measurements. A negative change from Baseline indicated improvement. | Baseline, Week 12 | 
| Percentage of Participants With ≥15% Reduction in Mean Diurnal IOP From Baseline | IOP is a measurement of the fluid pressure in the eye. The mean diurnal IOP was the average of the IOP values of the study eye (worse eye) measured at 8 AM, 12 Noon and 4 PM. For each eye, IOP was either the average of 2 measurements, or, if a third measurement was required, the average of 3 measurements. | Baseline, Week 12 | 
| Percentage of Participants With Mean Diurnal IOP Less Than 18 mmHg | IOP is a measure of the fluid pressure in the eye. The mean diurnal IOP was the average of the IOP values of the study eye (worse eye) at Week 12 measured at 8 AM, 12 Noon and 4 PM. For each eye, IOP was either the average of 2 measurements, or, if a third measurement was required, the average of 3 measurements. | Week 12 | 
| Change From Baseline in Mean IOP at Week 6 | IOP is a measurement of the fluid pressure inside the eye. IOP of the study eye (worse eye) was measured at 8 AM, 12 Noon and 4 PM at Week 6. For each eye, IOP was either the average of 2 measurements, or, if a third measurement was required, the average of 3 measurements. A negative change from Baseline indicated improvement. | Baseline, Week 6 |