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

This study is currently recruiting participants.

Verified by QLT Plug Delivery, Inc., January 2009

Sponsored by:	QLT Plug Delivery, Inc.
Information provided by:	QLT Plug Delivery, Inc.
ClinicalTrials.gov Identifier:	NCT00820300

Purpose

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.

Condition	Intervention	Phase
Glaucoma Ocular Hypertension	Drug: Latanoprost-PPDS	Phase II

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Glaucoma High Blood Pressure

Drug Information available for: Latanoprost BaseLine

U.S. FDA Resources

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

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

Primary Outcome Measures:

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

Estimated Enrollment:	40
Study Start Date:	January 2009
Estimated Study Completion Date:	July 2009
Estimated Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Punctal plug: Experimental	Drug: Latanoprost-PPDS Control of IOP compared to baseline for the experimental dose of Latanoprost-PPDS for 4 months or until loss of efficacy.

Eligibility

Ages Eligible for Study:	18 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00820300

Contacts

Contact: Oscar Cuzzani, MD

1-800-663-5486

ocuzzani@qltinc.com

Locations

United States, Missouri
	Recruiting
St. Louis, Missouri, United States, 63131

Sponsors and Collaborators

QLT Plug Delivery, Inc.

Investigators

Study Director:

Oscar Cuzzani, MD

QLT Inc

More Information

Responsible Party:	QLT Inc. ( Study Manager )
Study ID Numbers:	PPL GLAU 03
Study First Received:	January 8, 2009
Last Updated:	January 9, 2009
ClinicalTrials.gov Identifier:	NCT00820300
Health Authority:	United States: Food and Drug Administration

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 16, 2009