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

NCT ID: NCT01229982

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

121 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2011-08-31

Brief Summary

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The purpose of this study is to test if latanoprost punctal plugs will reduce eye pressure in subjects with ocular hypertension or open-angle glaucoma.

Detailed Description

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Conditions

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Ocular Hypertension Open Angle Glaucoma

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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L-PPDS

Group Type EXPERIMENTAL

Latanoprost-PPDS

Intervention Type DRUG

Punctal Plug

Interventions

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Latanoprost-PPDS

Punctal Plug

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosed with bilateral OH or OAG and on topical prostaglandin monotherapy bilaterally as standard of care for treatment of OH or OAG.
* Adequate IOP control on topical prostaglandin monotherapy during the past 1 month.

Exclusion Criteria

* Functionally significant vision loss, or progressive field loss within the last year.
* Contact lens wear at any time during the treatment period.
* Keratoconjunctivitis sicca requiring chronic topical artificial tears, lubricants, and/or Restasis®.
* Active lid disease (i.e., moderate or severe blepharitis, meibomianitis) that requires medical treatment.
* Subjects with ≥0.9 vertical cup or completely notched optic nerve head rim.
* Currently on chronic ocular topical medications
* Currently on any ophthalmic or systemic steroid therapy.
* Laser surgery for glaucoma within the last 3 months or 6 months for incisional surgeries.
* History of macular edema
* History of chronic/recurrent inflammatory eye disease.
* History of a non-response to topical prostaglandin therapy.
* Subjects who have epiphora.
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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QLT Inc.

Vancouver, British Columbia, Canada

Site Status

Countries

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United States Canada

Other Identifiers

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PPL GLAU 11

Identifier Type: -

Identifier Source: org_study_id