A Phase 2 Study of the Latanoprost Punctal Plug Delivery System in Subjects With Ocular Hypertension or Open-Angle Glaucoma

This study has been withdrawn prior to enrollment.

(Sponsor's decision)

Sponsor:

Information provided by:

QLT Inc.

ClinicalTrials.gov Identifier:

NCT00855517

First received: March 2, 2009

Last updated: March 1, 2011

Last verified: March 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

March 2, 2009

Last Updated Date

March 1, 2011

Start Date ^ICMJE

March 2009

Estimated Primary Completion Date

July 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

IOP change from baseline [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00855517 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

A Phase 2 Study of the Latanoprost Punctal Plug Delivery System in Subjects With Ocular Hypertension or Open-Angle Glaucoma

Official Title ^ICMJE

A Partially Masked, Phase 2 Study of the Latanoprost Punctal Plug Delivery System (L-PPDS) in Subjects With Ocular Hypertension (OH) or Open-Angle Glaucoma (OAG)

Brief Summary

The purpose of this study is to evaluate IOP response to experimental dose of Latanoprost- PPDS in subjects with ocular hypertension or open-angle glaucoma.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Glaucoma
Ocular Hypertension

Intervention ^ICMJE

Drug: Latanoprost-PPDS

Control of IOP compared to baseline for the experimental dose of Latanoprost-PPDS for 6 weeks or until loss of efficacy.

Study Arm (s)

Experimental: Punctal Plug

Intervention: Drug: Latanoprost-PPDS

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Withdrawn

Estimated Enrollment ^ICMJE

Estimated Completion Date

July 2009

Estimated Primary Completion Date

July 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Over 18 yrs of age 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 artifical tears, lubricants and/or requiring any other chronic topical medications
Subjects who have a history of chronic or recurrent inflammatory eye disease

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00855517

Other Study ID Numbers ^ICMJE

PPL GLAU 06

Has Data Monitoring Committee

Responsible Party

Study Manager, QLT Inc.

Study Sponsor ^ICMJE

QLT Inc.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Oscar Cuzzani, MD

QLT Inc.

Information Provided By

QLT Inc.

Verification Date

March 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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