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A Phase 2 Study of Punctal Placement of the Latanoprost Punctal Plug Delivery System (L-PPDS)

NCT ID: NCT00821002

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

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2009-11-30

Brief Summary

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The study objective is to compare IOP and safety outcomes based on plug placement (upper or lower puncta).

Detailed Description

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Conditions

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Open-Angle Glaucoma Ocular Hypertension

Keywords

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Glaucoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Plug placement

Group Type EXPERIMENTAL

Latanoprost

Intervention Type DRUG

Comparison of punctal plug placement between upper and lower puncta

Interventions

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Latanoprost

Comparison of punctal plug placement between upper and lower puncta

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Over 18 years
* Diagnosed with bilateral Open-Angle Glaucoma or Ocular Hypertension

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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QLT Inc.

INDUSTRY

Sponsor Role collaborator

Mati Therapeutics Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Oscar Cuzanni, MD, MSc

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 05

Identifier Type: -

Identifier Source: org_study_id