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

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

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

Official Title ^†

An Open-Label, 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 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

Study Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Primary Outcome Measure ^†

IOP change from baseline [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measure ^†

Condition ^†

Glaucoma
Ocular Hypertension

Intervention ^†

Drug: Latanoprost-PPDS

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Recruiting

Enrollment ^†

Start Date ^†

January 2009

Completion Date

July 2009

Eligibility Criteria ^†

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.

Gender

Both

Ages

18 Years to 90 Years

Accepts Healthy Volunteers

Contacts ^††

Contact: Oscar Cuzzani, MD

1-800-663-5486

ocuzzani@qltinc.com

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00820300

Organization ID

PPL GLAU 03

Secondary IDs ^††

Study Sponsor ^†

QLT Plug Delivery, Inc.

Collaborators ^††

Investigators ^†

Study Director:

Oscar Cuzzani, MD

QLT Inc

Information Provided By

QLT Plug Delivery, Inc.

Verification Date

January 2009

First Received Date ^†

January 8, 2009

Last Updated Date

January 9, 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.