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

Primary Purpose

Ocular Hypertension, Open Angle Glaucoma

Status
Completed
Phase
Phase 2
Locations
Canada
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 Ocular Hypertension

Eligibility Criteria

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

Inclusion Criteria:

  • Diagnosed with bilateral OH or OAG and on topical prostaglandin monotherapy bilaterally as standard of care for treatment of OH or OAG.
  • Adequate IOP control on topical prostaglandin monotherapy during the past 1 month.

Exclusion Criteria:

  • Functionally significant vision loss, or progressive field loss within the last year.
  • Contact lens wear at any time during the treatment period.
  • Keratoconjunctivitis sicca requiring chronic topical artificial tears, lubricants, and/or Restasis®.
  • Active lid disease (i.e., moderate or severe blepharitis, meibomianitis) that requires medical treatment.
  • Subjects with ≥0.9 vertical cup or completely notched optic nerve head rim.
  • Currently on chronic ocular topical medications
  • Currently on any ophthalmic or systemic steroid therapy.
  • Laser surgery for glaucoma within the last 3 months or 6 months for incisional surgeries.
  • History of macular edema
  • History of chronic/recurrent inflammatory eye disease.
  • History of a non-response to topical prostaglandin therapy.
  • Subjects who have epiphora.

Sites / Locations

  • QLT Inc.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

L-PPDS

Arm Description

Outcomes

Primary Outcome Measures

IOP change from baseline at 4 weeks
4 Weeks minus baseline

Secondary Outcome Measures

Full Information

First Posted
October 27, 2010
Last Updated
September 16, 2013
Sponsor
Mati Therapeutics Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01229982
Brief Title
A Study Evaluating the Latanoprost Punctal Plug Delivery System (L-PPDS) in Subjects With Ocular Hypertension or Open-Angle Glaucoma
Official Title
A Phase 2 Study Evaluating Safety and Efficacy 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
October 2010 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (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 test if latanoprost punctal plugs will reduce eye pressure in subjects with ocular hypertension or open-angle glaucoma.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ocular Hypertension, Open Angle Glaucoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
121 (Actual)

8. Arms, Groups, and Interventions

Arm Title
L-PPDS
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Latanoprost-PPDS
Intervention Description
Punctal Plug
Primary Outcome Measure Information:
Title
IOP change from baseline at 4 weeks
Description
4 Weeks minus baseline
Time Frame
Baseline to 4 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosed with bilateral OH or OAG and on topical prostaglandin monotherapy bilaterally as standard of care for treatment of OH or OAG. Adequate IOP control on topical prostaglandin monotherapy during the past 1 month. Exclusion Criteria: Functionally significant vision loss, or progressive field loss within the last year. Contact lens wear at any time during the treatment period. Keratoconjunctivitis sicca requiring chronic topical artificial tears, lubricants, and/or Restasis®. Active lid disease (i.e., moderate or severe blepharitis, meibomianitis) that requires medical treatment. Subjects with ≥0.9 vertical cup or completely notched optic nerve head rim. Currently on chronic ocular topical medications Currently on any ophthalmic or systemic steroid therapy. Laser surgery for glaucoma within the last 3 months or 6 months for incisional surgeries. History of macular edema History of chronic/recurrent inflammatory eye disease. History of a non-response to topical prostaglandin therapy. Subjects who have epiphora.
Facility Information:
Facility Name
QLT Inc.
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5T 4T5
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

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