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A Dose Evaluation Study for the Latanoprost Punctal Plug Delivery System (L-PPDS) in Subjects With Ocular Hypertension or Open-Angle Glaucoma

Primary Purpose

Glaucoma, Ocular Hypertension (OH)

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Latanoprost-PPDS
Sponsored by
Mati Therapeutics Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 medication conditions

Sites / Locations

  • Sall Research Medical Center, Inc
  • Wolstan & Goldberg Eye Associates
  • West Coast Eye Care Associates
  • Coastal Research Associates, LLC
  • R and R Eye Associates
  • Rocky Mountain Eye Care Associates

Outcomes

Primary Outcome Measures

IOP change from baseline

Secondary Outcome Measures

Full Information

First Posted
November 25, 2011
Last Updated
September 19, 2013
Sponsor
Mati Therapeutics Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01481051
Brief Title
A Dose Evaluation Study for the Latanoprost Punctal Plug Delivery System (L-PPDS) in Subjects With Ocular Hypertension or Open-Angle Glaucoma
Official Title
PPL GLAU 12: A Phase 2 Dose Evaluation Study for the Latanoprost Punctal Plug Delivery System (L-PPDS) in Subjects With Ocular Hypertension (OH) or Open-Angle Glaucoma (OAG)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mati Therapeutics Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the efficacy, safety and duration of the L-PPDS (latanoprost punctal plug delivery system) at different dose levels.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Ocular Hypertension (OH)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
57 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Latanoprost-PPDS
Intervention Description
Sustained delivery for 12 weeks
Primary Outcome Measure Information:
Title
IOP change from baseline
Time Frame
12 weeks to baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 medication conditions
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suzanne Cadden
Organizational Affiliation
QLT Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Sall Research Medical Center, Inc
City
Artesia
State/Province
California
ZIP/Postal Code
90701
Country
United States
Facility Name
Wolstan & Goldberg Eye Associates
City
Los Angeles
State/Province
California
ZIP/Postal Code
90505
Country
United States
Facility Name
West Coast Eye Care Associates
City
San Diego
State/Province
California
ZIP/Postal Code
92115
Country
United States
Facility Name
Coastal Research Associates, LLC
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30076
Country
United States
Facility Name
R and R Eye Associates
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Rocky Mountain Eye Care Associates
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States

12. IPD Sharing Statement

Learn more about this trial

A Dose Evaluation Study for the Latanoprost Punctal Plug Delivery System (L-PPDS) in Subjects With Ocular Hypertension or Open-Angle Glaucoma

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