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

NCT ID: NCT01481051

Last Updated: 2013-09-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2012-09-30

Brief Summary

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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

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Conditions

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Glaucoma Ocular Hypertension (OH)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Latanoprost-PPDS

Sustained delivery for 12 weeks

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mati Therapeutics Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Suzanne Cadden

Role: STUDY_DIRECTOR

QLT Inc.

Locations

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Sall Research Medical Center, Inc

Artesia, California, United States

Site Status

Wolstan & Goldberg Eye Associates

Los Angeles, California, United States

Site Status

West Coast Eye Care Associates

San Diego, California, United States

Site Status

Coastal Research Associates, LLC

Roswell, Georgia, United States

Site Status

R and R Eye Associates

San Antonio, Texas, United States

Site Status

Rocky Mountain Eye Care Associates

Salt Lake City, Utah, United States

Site Status

Countries

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United States

Other Identifiers

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PPL GLAU 12

Identifier Type: -

Identifier Source: org_study_id