A Safety Study of the Latanoprost Punctal Plug Delivery System (L-PPDS) in Subjects With Ocular Hypertension or Open Angle Glaucoma

Phase 2CompletedNCT00820300

Mati Therapeutics Inc.113 enrolled

Overview

The purpose of this study is to determine if the Punctal Plug Delivery System is safe and effective in controlling intraocular pressure in patients with ocular hypertension or open-angle glaucoma.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

113

Conditions

Glaucoma Ocular Hypertension

Interventions

Latanoprost-PPDSDRUG

Control of IOP compared to baseline for the experimental doses of Latanoprost-PPDS for 4 months or until loss of efficacy.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Over 18 yrs with ocular hypertension or open-angle glaucoma * Subjects who have a best-corrected visual acuity of 20/100 or better. Exclusion Criteria: * Subjects who wear contact lenses. * Uncontrolled medical conditions * Subjects requiring chronic topical artificial tears, lubricants, and/or requiring any other chronic topical medications. * Subjects who have a history of chronic or recurrent inflammatory eye disease.

Locations (1)

Unnamed facility

Menlo Park, California, United States

Outcomes

Primary Outcomes

IOP change from baseline

Time frame: 6 weeks

Data from ClinicalTrials.gov

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