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

This study is currently recruiting participants.

Verified by QLT Plug Delivery, Inc., January 2009

Sponsors and Collaborators:	QLT Plug Delivery, Inc. 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

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Glaucoma High Blood Pressure

Drug Information available for: Latanoprost

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)

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
Estimated Study Completion Date:	April 2009
Estimated Primary Completion Date:	March 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

Contacts

Contact: Sue-Anne Crocker

1-800-663-5486

Locations

United States, Missouri
	Recruiting
Des Peres, Missouri, United States, 63131

Sponsors and Collaborators

QLT Plug Delivery, Inc.

QLT Inc

Investigators

Study Director:

Oscar Cuzanni, MD, MSc

QLT Inc

More Information

Responsible Party:	QLT Inc., ( Study Manager )
Study ID Numbers:	PPL GLAU 05
Study First Received:	January 8, 2009
Last Updated:	January 9, 2009
ClinicalTrials.gov Identifier:	NCT00821002
Health Authority:	United States: Food and Drug Administration

Keywords provided by QLT Plug Delivery, Inc.:

Glaucoma

Study placed in the following topic categories:

Glaucoma
Eye Diseases
Glaucoma, Open-Angle
Vascular Diseases

Latanoprost
Hypertension
Ocular Hypertension

Additional relevant MeSH terms:

Therapeutic Uses
Cardiovascular Diseases
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 13, 2009