Status:
COMPLETED
A Dose Evaluation Study of the Effect of Plug Placement on the Efficacy and Safety of the Latanoprost Punctal Plug Delivery System (L-PPDS) in Subjects With Ocular Hypertension or Open-Angle Glaucoma
Lead Sponsor:
Mati Therapeutics Inc.
Conditions:
Glaucoma
Ocular Hypertension (OH)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine the effect of plug placement on the efficacy, safety and duration of effect of the L-PPDS (latanoprost punctal plug delivery system).
Eligibility Criteria
Inclusion
- Male or female at least 18 years old
- Diagnosis of bilateral open angle glaucoma or ocular hypertension
- Unmedicated IOP must be ≥22mm Hg
Exclusion
- Any significant vision loss in the last year
- No contact lens use for the length of the study
- Abnormal eye lids, eye infection or diseases to the eye
- Recent eye surgery
- Uncontrolled medical conditions
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
77 Patients enrolled
Trial Details
Trial ID
NCT01481077
Start Date
November 1 2011
End Date
September 1 2012
Last Update
September 26 2013
Active Locations (11)
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1
Vold Vision
Springdale, Arkansas, United States, 72762
2
Glaucoma Consultants of Colorado, PC
Denver, Colorado, United States, 80134
3
Danbury Eye Physicians & Surgeons
Danbury, Connecticut, United States, 06810
4
Ophthalmology Consultants Inc.
Des Peres, Missouri, United States, 63131