Safety and Efficacy of Punctum Plug Delivery System in Subjects With Open-Angle Glaucoma or Ocular Hypertension

NCT ID: NCT00650702

Last Updated: 2013-09-19

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

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2009-02-28

Brief Summary

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The purpose of this study is to determine if the Punctum Plug Delivery System (PPDS) is safe and effective in controlling intraocular pressure in patients with open-angle glaucoma or ocular hypertension.

Detailed Description

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Conditions

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Glaucoma Ocular Hypertension

Keywords

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glaucoma, ocular hypertension, IOP

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Low Latanoprost-PPDS

Group Type EXPERIMENTAL

Latanoprost-PPDS

Intervention Type DRUG

Control of IOP compared to baseline for the low dose of Latanoprost-PPDS for 4 months or until loss of efficacy

2

Medium Latanoprost-PPDS

Group Type EXPERIMENTAL

Latanoprost-PPDS

Intervention Type DRUG

Control of IOP compared to baseline for the medium dose of Latanoprost-PPDS for 4 months or until loss of efficacy

3

High Latanoprost-PPDS

Group Type EXPERIMENTAL

Latanoprost-PPDS

Intervention Type DRUG

Control of IOP compared to baseline for the high dose of Latanoprost-PPDS for 4 months or until loss of efficacy

Interventions

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Latanoprost-PPDS

Control of IOP compared to baseline for the low dose of Latanoprost-PPDS for 4 months or until loss of efficacy

Intervention Type DRUG

Latanoprost-PPDS

Control of IOP compared to baseline for the medium dose of Latanoprost-PPDS for 4 months or until loss of efficacy

Intervention Type DRUG

Latanoprost-PPDS

Control of IOP compared to baseline for the high dose of Latanoprost-PPDS for 4 months or until loss of efficacy

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Over 18 yrs with open-angle glaucoma or ocular hypertension
* Subjects who have a best-corrected visual acuity of 20/100 or better.

Exclusion Criteria

* Uncontrolled medical conditions.
* Subjects who wear contact lenses.
* Subjects requiring chronic topical artificial tears, lubricants, and/or requiring any other chronic topical medications.
* Subjects who have a history of chronic or recurrent inflammatory eye disease.
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

Locations

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Artesia, California, United States

Site Status

Sacramento, California, United States

Site Status

Bel Air, Maryland, United States

Site Status

Minneapolis, Minnesota, United States

Site Status

St Louis, Missouri, United States

Site Status

Lynbrook, New York, United States

Site Status

High Point, North Carolina, United States

Site Status

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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PPL GLAU 02

Identifier Type: -

Identifier Source: org_study_id