A Study of Different Formulations of the L-PPDS in Subjects With OH or OAG - Full Text View

Sponsor:	QLT Inc
Information provided by:	QLT Inc
ClinicalTrials.gov Identifier:	NCT00967811

Purpose

The purpose of this study is to evaluate the safety and preliminary efficacy of two formulations of the Latanoprost-PPDS in subjects with ocular hypertension or open-angle glaucoma.

Condition	Intervention	Phase
Glaucoma Ocular Hypertension	Drug: Formulation E1 of L-PPDS Drug: Formulation E2 of L-PPDS	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 Different Formulations (E1 and E2) 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: Tuberculin Purified Protein Derivative Latanoprost

U.S. FDA Resources

Further study details as provided by QLT Inc:

Primary Outcome Measures:

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

Enrollment:	83
Study Start Date:	August 2009
Study Completion Date:	May 2010
Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1. Formulation E1 Formulation E1 of Latanoprost-PPDS	Drug: Formulation E1 of L-PPDS Control of IOP compared to baseline for Formulation E1 of the experimental dose of Latanoprost-PPDS for 6 weeks or until loss of efficacy.
Experimental: 2. Formulation E2 Formulation E2 of Latanoprost-PPDS	Drug: Formulation E2 of L-PPDS Control of IOP compared to baseline for Formulation E2 of 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:

Subjects over 18 years of age diagnosed 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
Subjects who have uncontrolled medical conditions
Subjects requiring chronic topical artificial tears, lubricants, and/or requiring any other chronic ocular 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: NCT00967811

Locations

United States, California

Menlo Park, California, United States, 94025

Sponsors and Collaborators

QLT Inc

Investigators

Study Director:

Oscar Cuzzani, MD

QLT Inc

More Information

No publications provided

Responsible Party:	Study Manager, QLT Inc.
ClinicalTrials.gov Identifier:	NCT00967811 History of Changes
Other Study ID Numbers:	PPL GLAU 07
Study First Received:	August 27, 2009
Last Updated:	June 27, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Glaucoma
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