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

Phase 2

Completed

• Conditions: Glaucoma; Ocular Hypertension (OH)

• Registration Number: NCT01481051
• Lead Sponsor: Mati Therapeutics Inc.

Brief Summary

The purpose of this study is to evaluate the efficacy, safety and duration of the L-PPDS (latanoprost punctal plug delivery system) at different dose levels.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2011-11-25
• Study First Submitted QC: 2011-11-25
• 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: 57

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 medication conditions

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
IOP change from baseline	12 weeks to baseline

Trial Locations

Locations (6)

Sall Research Medical Center, Inc; 🇺🇸 Artesia, California, United States

West Coast Eye Care Associates; 🇺🇸 San Diego, California, United States

Coastal Research Associates, LLC; 🇺🇸 Roswell, Georgia, United States

Rocky Mountain Eye Care Associates; 🇺🇸 Salt Lake City, Utah, United States

Wolstan & Goldberg Eye Associates; 🇺🇸 Los Angeles, California, United States

R and R Eye Associates; 🇺🇸 San Antonio, Texas, United States