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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

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ClinicalTrials.gov Identifier: NCT01881126
Recruitment Status : Completed
First Posted : June 19, 2013
Results First Posted : November 30, 2015
Last Update Posted : November 30, 2015
Sponsor:
Information provided by (Responsible Party):
Allergan

Brief 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.

Condition or disease Intervention/treatment Phase
Glaucoma Ocular Hypertension Drug: bimatoprost 0.01% Drug: travatan 0.004% Drug: timolol 0.5% Drug: hypromellose 0.3% Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 93 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Study Start Date : June 2013
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014


Arm Intervention/treatment
Active Comparator: 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.
Drug: bimatoprost 0.01%
Bimatoprost 0.01% administered to both eyes once daily for 12 weeks.
Other Names:
  • Lumigan® RC
  • Lumigan®

Drug: hypromellose 0.3%
Hypromellose 0.3% lubricant eye drops (for masking purposes) administered to both eyes once daily for 12 weeks.
Other Name: GenTeal®

Active Comparator: travatan 0.004% and timolol 0.5%
Travatan 0.004% and timolol 0.5% each 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.
Other Name: Travatan Z®

Drug: timolol 0.5%
Timolol 0.5% administered to both eyes once daily for 12 weeks.
Other Names:
  • Timolol Maleate-EX
  • Timolol GFS




Primary Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01881126


Locations
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Canada, Ontario
Barrie, Ontario, Canada
Toronto, Ontario, Canada
Sponsors and Collaborators
Allergan
Investigators
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Study Director: Medical Director Allergan

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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01881126     History of Changes
Other Study ID Numbers: GMA-LUM-12-021
First Posted: June 19, 2013    Key Record Dates
Results First Posted: November 30, 2015
Last Update Posted: November 30, 2015
Last Verified: October 2015

Additional relevant MeSH terms:
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Hypertension
Glaucoma
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Timolol
Bimatoprost
Travoprost
Lubricant Eye Drops
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Ophthalmic Solutions
Pharmaceutical Solutions