A Study of the L-PPDS With Adjunctive Xalatan® Eye Drops in Subjects With OH or OAG

NCT ID: NCT01037036

Last Updated: 2014-01-10

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

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2010-07-31

Brief Summary

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The objective of this study is to investigate how the intraocular pressure (IOP)-lowering effect of the L-PPDS is altered by adjunctive Xalatan therapy.

Detailed Description

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Conditions

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Ocular Hypertension Open-Angle Glaucoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Latanoprost Punctal Plug Delivery System followed by Xalatan

Subjects will have the Latanoprost Punctal Plug Delivery System placed for 4 week or until loss of efficacy. After removal of the Latanoprost Punctal Plug Delivery system, subjects will administer adjunctive Xalatan eye drops once daily for 2 weeks. This is a single arm study.

Group Type EXPERIMENTAL

Latanoprost Punctal Plug Delivery System

Intervention Type DRUG

To evaluate the control of IOP compared to baseline, for an experimental dose of Latanoprost Punctal Plug Delivery System for 4 week or until loss of efficacy. This is a single arm study.

Xalatan

Intervention Type DRUG

Subjects will administer adjunctive Xalatan eye drops once daily for 2 weeks. This is a single arm study.

Interventions

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Latanoprost Punctal Plug Delivery System

To evaluate the control of IOP compared to baseline, for an experimental dose of Latanoprost Punctal Plug Delivery System for 4 week or until loss of efficacy. This is a single arm study.

Intervention Type DRUG

Xalatan

Subjects will administer adjunctive Xalatan eye drops once daily for 2 weeks. This is a single arm study.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Over 18 years
* Diagnosed with bilateral Open-Angle Glaucoma or Ocular Hypertension
* Currently on prostaglandin therapy

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

Menlo Park, California, United States

Site Status

Countries

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United States

Other Identifiers

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PPL GLAU 08

Identifier Type: -

Identifier Source: org_study_id

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