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

NCT ID: NCT01547598

Last Updated: 2014-08-15

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

135 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2013-07-31

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.

Detailed Description

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Conditions

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Glaucoma, Open-Angle Ocular Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

travoprost ophthalmic solution 0.004%

Intervention Type DRUG

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

Bimatoprost ophthalmic solution 0.01%

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

travoprost ophthalmic solution 0.004%

Intervention Type 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 solution

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Travatan® Z DuoTrav® LUMIGAN® RC

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Allergan

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Allergan

Locations

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Vancouver, British Columbia, Canada

Site Status

Countries

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Canada

Other Identifiers

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GMA-LUM-11-020

Identifier Type: -

Identifier Source: org_study_id

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