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: NCT02097719
• Other study ID #: GMA-LUM-12-022
• Status: Completed
• Phase: Phase 4
• First received: March 25, 2014
• Last updated: December 9, 2015
• Start date: May 2014
• Est. completion date: December 2014

Study information

• Verified date: December 2015
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2014
• Est. primary completion date: December 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.
• travoprost 0.004%
Travoprost 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

United States, 

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