Safety and Efficacy of Punctum Plug Delivery System in Subjects With Open-Angle Glaucoma or Ocular Hypertension
NCT00650702 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36
Last updated 2013-09-19
Summary
The purpose of this study is to determine if the Punctum Plug Delivery System (PPDS) is safe and effective in controlling intraocular pressure in patients with open-angle glaucoma or ocular hypertension.
Conditions
Interventions
- DRUG
-
Latanoprost-PPDS
Control of IOP compared to baseline for the low dose of Latanoprost-PPDS for 4 months or until loss of efficacy
- DRUG
-
Latanoprost-PPDS
Control of IOP compared to baseline for the medium dose of Latanoprost-PPDS for 4 months or until loss of efficacy
- DRUG
-
Latanoprost-PPDS
Control of IOP compared to baseline for the high dose of Latanoprost-PPDS for 4 months or until loss of efficacy
Sponsors & Collaborators
-
Mati Therapeutics Inc.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2008-03-31
- Primary Completion
- 2009-02-28
- Completion
- 2009-02-28
Countries
- United States
Study Locations
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