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

Glaucoma Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01881126
• Other study ID #: GMA-LUM-12-021
• Status: Completed
• Phase: Phase 4
• First received: June 17, 2013
• Last updated: October 27, 2015
• Start date: June 2013
• Est. completion date: October 2014

Study information

• Verified date: October 2015
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma
• Hypertension
• Ocular Hypertension

Intervention

Drug:
• bimatoprost 0.01%
Bimatoprost 0.01% administered to both eyes once daily for 12 weeks.
• travatan 0.004%
Travatan 0.004% administered to both eyes once daily for 12 weeks.
• timolol 0.5%
Timolol 0.5% administered to both eyes once daily for 12 weeks.
• hypromellose 0.3%
Hypromellose 0.3% lubricant eye drops (for masking purposes) administered to both eyes once daily for 12 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraocular Pressure (IOP) in the Study Eye 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.	Week 12 at 8 AM, 12 PM, and 4 PM	No