Status:
COMPLETED
Bimatoprost Ocular Insert Compared to Topical Timolol Solution in Patients With Glaucoma or Ocular Hypertension
Lead Sponsor:
ForSight Vision5, Inc.
Conditions:
Primary Open-Angle Glaucoma
Ocular Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The objective of this Phase 2 study is to evaluate whether the Bimatoprost Ocular Insert is non-inferior to that of timolol ophthalmic solution (0.5%) at 12 weeks.
Eligibility Criteria
Inclusion
- Key
- Written informed consent
- Primary open-angle glaucoma or ocular hypertension in both eyes
- Best-corrected distance vision of 20/80 or better
- Stable visual field
- corneal thickness between 490-620 micrometers
- Key
Exclusion
- Cup-to-disc ratio greater than 0.8
- significant risk of angle closure due to pupil dilation, defined as a Shaffer classification of less than grade 2 based on gonioscopy
- laser surgery for glaucoma/ocular hypertension on one or both eyes within the last 12 months
- past history of corneal refractive surgery
- past history of any incisional surgery for glaucoma at any time
- corneal abnormalities that would interfere with tonometry readings
- current participation in an investigational drug or device study or participation in such a study within 30 days of screening
- Inability to accurately evaluate the retina
Key Trial Info
Start Date :
October 23 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 14 2014
Estimated Enrollment :
169 Patients enrolled
Trial Details
Trial ID
NCT01915940
Start Date
October 23 2013
End Date
November 14 2014
Last Update
April 20 2018
Active Locations (10)
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1
Sall Medical Research Center
Artesia, California, United States, 90701
2
Scripps Clinic Torrey Pines
La Jolla, California, United States, 92037
3
Eye Research Foundation
Newport Beach, California, United States, 92663
4
UC Davis Dept of Ophthalmology & Vision Science
Sacramento, California, United States, 95817