A Phase 2 Study of the Latanoprost Punctal Plug Delivery System in Subjects With Ocular Hypertension or Open-Angle Glaucoma

This study has been withdrawn prior to recruitment.

( Sponsor's decision )

First Received: March 2, 2009 Last Updated: June 2, 2009 History of Changes

Sponsored by:	QLT Plug Delivery, Inc.
Information provided by:	QLT Plug Delivery, Inc.
ClinicalTrials.gov Identifier:	NCT00855517

Purpose

The purpose of this study is to evaluate IOP response to experimental dose of Latanoprost- PPDS in subjects with ocular hypertension or open-angle glaucoma.

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

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Partially Masked, Phase 2 Study of the Latanoprost Punctal Plug Delivery 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

U.S. FDA Resources

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

Primary Outcome Measures:

IOP change from baseline [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	March 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 6 weeks or until loss of efficacy.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Over 18 yrs of age 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 artifical 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: NCT00855517

Locations

United States, Florida

Miami, Florida, United States, 33176

Sponsors and Collaborators

QLT Plug Delivery, Inc.

Investigators

Study Director:

Oscar Cuzzani, MD

QLT Inc

More Information

No publications provided

Responsible Party:	QLT Inc. ( Study Manager )
Study ID Numbers:	PPL GLAU 06
Study First Received:	March 2, 2009
Last Updated:	June 2, 2009
ClinicalTrials.gov Identifier:	NCT00855517 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Glaucoma
Eye Diseases
Glaucoma, Open-Angle
Vascular Diseases
Cardiovascular Agents

Antihypertensive Agents
Latanoprost
Hypertension
Ocular Hypertension

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 September 11, 2009