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An Efficacy and Safety Study of Bimatoprost 0.01% Alone Compared With Travoprost 0.004% and Timolol 0.5% in Subjects With Glaucoma or Ocular Hypertension

NCT ID: NCT01881126

Last Updated: 2015-11-30

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

93 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2014-10-31

Brief Summary

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This efficacy and safety study will evaluate LUMIGAN® RC/ LUMIGAN® .01 (bimatoprost 0.01%) alone compared to TRAVATAN Z® (travoprost 0.004%) and TIMOLOL MALEATE-EX, 0.5%/TIMOLOL GFS 0.5% (timolol 0.5% ophthalmic gel forming solution) in patients who require IOP lowering therapy.

Detailed Description

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Conditions

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Glaucoma 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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bimatoprost 0.01% and hypromellose 0.3%

Bimatoprost 0.01% and hypromellose 0.3% lubricant eye drops (for masking purposes) each administered to both eyes once daily for 12 weeks.

Group Type ACTIVE_COMPARATOR

bimatoprost 0.01%

Intervention Type DRUG

Bimatoprost 0.01% administered to both eyes once daily for 12 weeks.

hypromellose 0.3%

Intervention Type DRUG

Hypromellose 0.3% lubricant eye drops (for masking purposes) administered to both eyes once daily for 12 weeks.

travatan 0.004% and timolol 0.5%

Travatan 0.004% and timolol 0.5% each administered to both eyes once daily for 12 weeks.

Group Type ACTIVE_COMPARATOR

travatan 0.004%

Intervention Type DRUG

Travatan 0.004% administered to both eyes once daily for 12 weeks.

timolol 0.5%

Intervention Type DRUG

Timolol 0.5% administered to both eyes once daily for 12 weeks.

Interventions

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bimatoprost 0.01%

Bimatoprost 0.01% administered to both eyes once daily for 12 weeks.

Intervention Type DRUG

travatan 0.004%

Travatan 0.004% administered to both eyes once daily for 12 weeks.

Intervention Type DRUG

timolol 0.5%

Timolol 0.5% administered to both eyes once daily for 12 weeks.

Intervention Type DRUG

hypromellose 0.3%

Hypromellose 0.3% lubricant eye drops (for masking purposes) administered to both eyes once daily for 12 weeks.

Intervention Type DRUG

Other Intervention Names

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Lumigan® RC Lumigan® Travatan Z® Timolol Maleate-EX Timolol GFS GenTeal®

Eligibility Criteria

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Inclusion Criteria

* Ocular hypertension or glaucoma that requires treatment with medication
* Have a best corrected visual acuity (BCVA) of 20/100 or better in both eyes

Exclusion Criteria

* History of LASIK, LASEK, RK, and/or PRK in the study eye(s)
* History of any intraocular surgery or glaucoma laser surgery in the study eye(s) within 3 months
* Use of topical, periorbital, intravitreal or systemic steroid within 3 months or expected use during the course of study
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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Barrie, Ontario, Canada

Site Status

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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GMA-LUM-12-021

Identifier Type: -

Identifier Source: org_study_id