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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Investigator)
  • Study Primary Completion Date: July 2013

Interventions

  • Drug: travoprost ophthalmic solution 0.004%
    • Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks.
  • Drug: travoprost 0.004% / timolol 0.5% combination ophthalmic solution
    • 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: Bimatoprost ophthalmic solution 0.01%
    • LUMIGAN® RC (bimatoprost ophthalmic solution 0.01%) administered as 1 drop in the affected eye(s) once daily in the evening for 12 weeks.

Arms, Groups and Cohorts

  • Active Comparator: LUMIGAN® RC
    • 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.
  • Active Comparator: DuoTrav®
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Mean Diurnal Intraocular Pressure (IOP)
    • Time Frame: Week 12
    • 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.

Secondary Measures

  • Change From Baseline in Mean IOP at Week 12
    • Time Frame: Baseline, 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.
  • Percentage of Participants With ≥15% Reduction in Mean Diurnal IOP From Baseline
    • Time Frame: Baseline, Week 12
    • 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.
  • Percentage of Participants With Mean Diurnal IOP Less Than 18 mmHg
    • Time Frame: Week 12
    • 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.
  • Change From Baseline in Mean IOP at Week 6
    • Time Frame: Baseline, 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Allergan
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Medical Director, Study Director, Allergan

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