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

This study has been completed.

First Received: January 8, 2009 Last Updated: November 27, 2009 History of Changes

Sponsor:	QLT Plug Delivery, Inc.
Collaborator:	QLT Inc
Information provided by:	QLT Plug Delivery, Inc.
ClinicalTrials.gov Identifier:	NCT00821002

Purpose

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

Condition	Intervention	Phase
Open-Angle Glaucoma Ocular Hypertension	Drug: Latanoprost	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
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)

Resource links provided by NLM:

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Glaucoma High Blood Pressure

Drug Information available for: Latanoprost

Further study details as provided by QLT Plug Delivery, Inc.:

Primary Outcome Measures:

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

Estimated Enrollment:	30
Study Start Date:	January 2009
Study Completion Date:	November 2009
Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Plug placement: Experimental	Drug: Latanoprost Comparison of punctal plug placement between upper and lower puncta

Eligibility

Criteria

Inclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00821002

Locations

United States, California

Menlo Park, California, United States, 94025

Sponsors and Collaborators

QLT Plug Delivery, Inc.

QLT Inc

Investigators

Study Director:

Oscar Cuzanni, MD, MSc

QLT Inc

More Information

No publications provided

Responsible Party:	QLT Inc., ( Study Manager )
Study ID Numbers:	PPL GLAU 05
Study First Received:	January 8, 2009
Last Updated:	November 27, 2009
ClinicalTrials.gov Identifier:	NCT00821002 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by QLT Plug Delivery, Inc.:

Glaucoma

Additional relevant MeSH terms:

Glaucoma
Therapeutic Uses
Eye Diseases
Glaucoma, Open-Angle
Vascular Diseases
Cardiovascular Diseases

Cardiovascular Agents
Antihypertensive Agents
Latanoprost
Pharmacologic Actions
Ocular Hypertension
Hypertension

ClinicalTrials.gov processed this record on February 08, 2010