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

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

Descriptive Information Fields

Brief Title ^†

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

Official Title ^†

An Open-Label, Phase 2 Study of Punctal Placement of the Latanoprost Punctal Plug System (L-PPDS) in Subjects With Ocular Hypertension (OH) or Open-Angle Glaucoma (OAG)

Brief Summary

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

Detailed Description

Study Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment, Non-Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

Primary Outcome Measure ^†

Compare intraocular pressure and safety outcomes based on plug placement [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measure ^†

Condition ^†

Open-Angle Glaucoma
Ocular Hypertension

Intervention ^†

Drug: Latanoprost

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Recruiting

Enrollment ^†

Start Date ^†

January 2009

Completion Date

April 2009

Eligibility Criteria ^†

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Contact: Sue-Anne Crocker

1-800-663-5486

medaffairs@qltinc.com

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00821002

Organization ID

PPL GLAU 05

Secondary IDs ^††

Study Sponsor ^†

QLT Plug Delivery, Inc.

Collaborators ^††

QLT Inc

Investigators ^†

Study Director:

Oscar Cuzanni, MD, MSc

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.