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

Phase 2

Completed

• Conditions: Ocular Hypertension (OH); Glaucoma
• Interventions: Drug: Latanoprost-PPDS

• Registration Number: NCT01481077
• Lead Sponsor: Mati Therapeutics Inc.

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2011-11-25
• Study First Submitted QC: 2011-11-28
• Study First Posted: 2011-11-29
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Status Verified: 2013-09
• Disposition First Submitted: 2013-09-16
• Disposition First Submitted QC: 2013-09-16
• Disposition First Posted: 2013-09-19
• Last Update Submitted: 2013-09-19
• Last Update Posted: 2013-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 77

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment B	Latanoprost-PPDS	-
Treatment A	Latanoprost-PPDS	-
Treatment C	Latanoprost-PPDS	-

Primary Outcome Measures

Name	Time	Method
IOP change from baseline	12 weeks to baseline

Trial Locations

Locations (11)

Las Vegas Physicians Research Group; 🇺🇸 Henderson, Nevada, United States

Total Eye Care, P.A.; 🇺🇸 Memphis, Tennessee, United States

Vold Vision; 🇺🇸 Springdale, Arkansas, United States

Ophthalmology Consultants Inc.; 🇺🇸 Des Peres, Missouri, United States

Glaucoma Consultants of Colorado, PC; 🇺🇸 Denver, Colorado, United States

Danbury Eye Physicians & Surgeons; 🇺🇸 Danbury, Connecticut, United States

Ophthalmology Associates; 🇺🇸 St. Louis, Missouri, United States

Comprehensive Eye Care, Ltd; 🇺🇸 Washington, Missouri, United States

Abrams Eye Institute; 🇺🇸 Las Vegas, Nevada, United States

Philadelphia Eye Associates; 🇺🇸 Philadelphia, Pennsylvania, United States

University Eye Surgeons; 🇺🇸 Maryville, Tennessee, United States