Skip to main content
OpenTrials
Completed

NCT Number: NCT01547598

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Glaucoma, Open-Angle Eye Diseases Glaucoma Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Vancouver, British Columbia, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Travatan® Z

travoprost 0.004% / timolol 0.5% combination ophthalmic solution

Drug

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.

Other names: DuoTrav®

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.

Other names: LUMIGAN® RC

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Mar 8, 2012
Registry last updated
Aug 15, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.