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

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).

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Key information

Conditions

Glaucoma Eye Diseases Ocular Hypertension Ocular Hypertension (OH)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Vold Vision, Springdale, Arkansas, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Male or female at least 18 years old
Diagnosis of bilateral open angle glaucoma or ocular hypertension
Unmedicated IOP must be ≥22mm Hg

Exclusion criteria

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

Treatment and study plan

Latanoprost-PPDS

Drug

Sustained release for 12 weeks

Primary outcomes

IOP change from baseline

Time frame: 12 weeks to baseline

Sponsors and collaborators

Lead sponsor

Mati Therapeutics Inc.

Industry

Registry information

Official study title

PPL GLAU 13: A Randomized Phase 2 Study of the Effect of Plug Placement on Efficacy and Safety of the Latanoprost Punctal Plug Delivery System (L-PPDS) in Subjects With Ocular Hypertension (OH) or Open-Angle Glaucoma (OAG)

Important dates

Study start: 2011
Primary completion: 2012
Study completion: 2012
First posted: Nov 29, 2011
Registry last updated: Sep 26, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed