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

This study has been completed.

First Received on January 8, 2009. Last Updated on June 27, 2011 History of Changes

Sponsor:	QLT Inc
Information provided by:	QLT 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:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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

U.S. FDA Resources

Further study details as provided by QLT Inc:

Primary Outcome Measures:

Intraocular pressure change from baseline (mmHg) [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Number of subjects with adverse events [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]

Enrollment:	32
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
Experimental: Plug placement	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 Inc

Investigators

Study Director:

Oscar Cuzanni, MD, MSc

QLT Inc

More Information

No publications provided

Responsible Party:	Study Manager, QLT Inc.,
ClinicalTrials.gov Identifier:	NCT00821002 History of Changes
Other Study ID Numbers:	PPL GLAU 05
Study First Received:	January 8, 2009
Last Updated:	June 27, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by QLT Inc:

Glaucoma

Additional relevant MeSH terms:

Glaucoma
Glaucoma, Open-Angle
Hypertension
Ocular Hypertension
Eye Diseases
Vascular Diseases

Cardiovascular Diseases
Latanoprost
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012