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

Allergan135 enrolled

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

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

135

Conditions

Glaucoma, Open-Angle Ocular Hypertension

Interventions

travoprost ophthalmic solution 0.004%DRUG

Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks.

travoprost 0.004% / timolol 0.5% combination ophthalmic solutionDRUG

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.

Bimatoprost ophthalmic solution 0.01%DRUG

LUMIGAN® RC (bimatoprost ophthalmic solution 0.01%) administered as 1 drop in the affected eye(s) once daily in the evening for 12 weeks.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

Vancouver, British Columbia, Canada

Outcomes

Primary Outcomes

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.

Time frame: Week 12

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

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