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

NCT ID: NCT00820300

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

113 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2009-12-31

Brief Summary

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

Detailed Description

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Conditions

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Glaucoma Ocular Hypertension

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Punctal plug

Group Type EXPERIMENTAL

Latanoprost-PPDS

Intervention Type DRUG

Control of IOP compared to baseline for the experimental doses 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 experimental doses 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 ocular hypertension or open-angle glaucoma
* Subjects who have a best-corrected visual acuity of 20/100 or better.

Exclusion Criteria

* Subjects who wear contact lenses.
* Uncontrolled medical conditions
* 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

Maximum Eligible Age

90 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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Oscar Cuzzani, MD

Role: STUDY_DIRECTOR

QLT Inc.

Locations

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Menlo Park, California, United States

Site Status

Countries

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United States

Other Identifiers

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PPL GLAU 03

Identifier Type: -

Identifier Source: org_study_id