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

NCT01881126 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 93

Last updated 2015-11-30

Study results available
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Summary

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.

Conditions

Interventions

DRUG

bimatoprost 0.01%

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

DRUG

travatan 0.004%

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

DRUG

timolol 0.5%

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

DRUG

hypromellose 0.3%

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

Sponsors & Collaborators

  • Allergan

    lead INDUSTRY

Principal Investigators

  • Medical Director · Allergan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2014-10-31
Completion
2014-10-31

Countries

  • Canada

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01881126 on ClinicalTrials.gov