Study of the Effects of Artificial Tears on the Response to the Latanoprost Punctal Plug Delivery System in Subjects With Ocular Hypertension or Open-Angle Glaucoma

Mati Therapeutics Inc.40 enrolled

Overview

The purpose of this study is to determine the effect of artificial tears preserved with Benzalkonium Chloride (AT-BAK) on the IOP response to the L-PPDS and to evaluate the safety of the L-PPDS in subjects with OH or OAG following treatment.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Glaucoma Ocular Hypertension

Interventions

Latanoprost punctal plugDRUG

Control of IOP compared to baseline for the experimental dose of Latanoprost punctal plug for 6 weeks or until loss of efficacy.

artificial tears preserved with Benzalkonium ChlorideDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Over 18 years 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 with a known sensitivity to latanoprost, BAK, or any other products required for the study * Subjects requiring chronic topical artificial tears, lubricants, and/or requiring any other chronic topical medications.

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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