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

NCT ID: NCT00967811

Last Updated: 2013-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

83 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2010-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Glaucoma Ocular Hypertension

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1. Formulation E1

Formulation E1 of Latanoprost-PPDS

Group Type EXPERIMENTAL

Formulation E1 of L-PPDS

Intervention Type DRUG

Control of IOP compared to baseline for Formulation E1 of the experimental dose of Latanoprost-PPDS for 6 weeks or until loss of efficacy.

2. Formulation E2

Formulation E2 of Latanoprost-PPDS

Group Type EXPERIMENTAL

Formulation E2 of L-PPDS

Intervention Type DRUG

Control of IOP compared to baseline for Formulation E2 of experimental dose of Latanoprost-PPDS for 6 weeks or until loss of efficacy.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mati Therapeutics Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Oscar Cuzzani, MD

Role: STUDY_DIRECTOR

QLT Inc.

Locations

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Menlo Park, California, United States

Site Status

Countries

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United States

Other Identifiers

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PPL GLAU 07

Identifier Type: -

Identifier Source: org_study_id