A Dose Evaluation Study of the Effect of Plug Placement on the Efficacy and Safety of the Latanoprost Punctal Plug Delivery System (L-PPDS) in Subjects With Ocular Hypertension or Open-Angle Glaucoma

NCT ID: NCT01481077

Last Updated: 2013-09-26

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

77 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2012-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to determine the effect of plug placement on the efficacy, safety and duration of effect of the L-PPDS (latanoprost punctal plug delivery system).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Glaucoma Ocular Hypertension (OH)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Treatment A

Group Type EXPERIMENTAL

Latanoprost-PPDS

Intervention Type DRUG

Sustained release for 12 weeks

Treatment B

Group Type EXPERIMENTAL

Latanoprost-PPDS

Intervention Type DRUG

Sustained release for 12 weeks

Treatment C

Group Type EXPERIMENTAL

Latanoprost-PPDS

Intervention Type DRUG

Sustained release for 12 weeks

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Latanoprost-PPDS

Sustained release for 12 weeks

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Male or female at least 18 years old
* Diagnosis of bilateral open angle glaucoma or ocular hypertension
* Unmedicated IOP must be ≥22mm Hg

Exclusion Criteria

* Any significant vision loss in the last year
* No contact lens use for the length of the study
* Abnormal eye lids, eye infection or diseases to the eye
* Recent eye surgery
* Uncontrolled medical conditions
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Mati Therapeutics Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Suzanne Cadden

Role: STUDY_DIRECTOR

QLT Inc.

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Vold Vision

Springdale, Arkansas, United States

Site Status

Glaucoma Consultants of Colorado, PC

Denver, Colorado, United States

Site Status

Danbury Eye Physicians & Surgeons

Danbury, Connecticut, United States

Site Status

Ophthalmology Consultants Inc.

Des Peres, Missouri, United States

Site Status

Ophthalmology Associates

St Louis, Missouri, United States

Site Status

Comprehensive Eye Care, Ltd

Washington, Missouri, United States

Site Status

Las Vegas Physicians Research Group

Henderson, Nevada, United States

Site Status

Abrams Eye Institute

Las Vegas, Nevada, United States

Site Status

Philadelphia Eye Associates

Philadelphia, Pennsylvania, United States

Site Status

University Eye Surgeons

Maryville, Tennessee, United States

Site Status

Total Eye Care, P.A.

Memphis, Tennessee, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PPL GLAU 13

Identifier Type: -

Identifier Source: org_study_id