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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

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
Arms
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 medical conditions

Sites / Locations

  • Vold Vision
  • Glaucoma Consultants of Colorado, PC
  • Danbury Eye Physicians & Surgeons
  • Ophthalmology Consultants Inc.
  • Ophthalmology Associates
  • Comprehensive Eye Care, Ltd
  • Las Vegas Physicians Research Group
  • Abrams Eye Institute
  • Philadelphia Eye Associates
  • University Eye Surgeons
  • Total Eye Care, P.A.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Treatment A

Treatment B

Treatment C

Arm Description

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
NCT01481077
Brief Title
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
Official Title
PPL GLAU 13: A Randomized Phase 2 Study of the Effect of Plug Placement on Efficacy and Safety of 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 determine the effect of plug placement on the efficacy, safety and duration of effect of the L-PPDS (latanoprost punctal plug delivery system).

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
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
77 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment A
Arm Type
Experimental
Arm Title
Treatment B
Arm Type
Experimental
Arm Title
Treatment C
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Latanoprost-PPDS
Intervention Description
Sustained release 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 medical 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
Vold Vision
City
Springdale
State/Province
Arkansas
ZIP/Postal Code
72762
Country
United States
Facility Name
Glaucoma Consultants of Colorado, PC
City
Denver
State/Province
Colorado
ZIP/Postal Code
80134
Country
United States
Facility Name
Danbury Eye Physicians & Surgeons
City
Danbury
State/Province
Connecticut
ZIP/Postal Code
06810
Country
United States
Facility Name
Ophthalmology Consultants Inc.
City
Des Peres
State/Province
Missouri
ZIP/Postal Code
63131
Country
United States
Facility Name
Ophthalmology Associates
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63131
Country
United States
Facility Name
Comprehensive Eye Care, Ltd
City
Washington
State/Province
Missouri
ZIP/Postal Code
63090
Country
United States
Facility Name
Las Vegas Physicians Research Group
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89052
Country
United States
Facility Name
Abrams Eye Institute
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89148
Country
United States
Facility Name
Philadelphia Eye Associates
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19148
Country
United States
Facility Name
University Eye Surgeons
City
Maryville
State/Province
Tennessee
ZIP/Postal Code
37803
Country
United States
Facility Name
Total Eye Care, P.A.
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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