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OpenTrials
Completed

NCT Number: NCT01881126

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

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.

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Key information

Conditions

Glaucoma Eye Diseases Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Barrie, Ontario, Canada

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Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Bimatoprost 0.01%

Drug

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

Other names: Lumigan® RC, Lumigan®

travatan 0.004%

Drug

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

Other names: Travatan Z®

Timolol 0.5%

Drug

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

Other names: Timolol Maleate-EX, Timolol GFS

hypromellose 0.3%

Drug

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

Other names: GenTeal®

Primary outcomes

  1. Intraocular Pressure (IOP) in the Study Eye at 8 AM, 12 PM, and 4 PM

    Time frame: Week 12 at 8 AM, 12 PM, and 4 PM

    IOP is a measurement of the fluid pressure inside the eye. IOP of the study eye (worse eye) is measured at 8 AM, 12 PM, and 4 PM. IOP is either the average of 2 measurements, or, if a third measurement is required, the average of 3 measurements.

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jun 19, 2013
Registry last updated
Nov 30, 2015

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.

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