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Safety and Efficacy of Punctum Plug Delivery System in Subjects With Open-Angle Glaucoma or Ocular Hypertension (CORE)

Primary Purpose

Glaucoma, Ocular Hypertension

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Latanoprost-PPDS
Latanoprost-PPDS
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 focused on measuring glaucoma, ocular hypertension, IOP

Eligibility Criteria

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

Inclusion Criteria:

  • Over 18 yrs with open-angle glaucoma or ocular hypertension
  • Subjects who have a best-corrected visual acuity of 20/100 or better.

Exclusion Criteria:

  • Uncontrolled medical conditions.
  • Subjects who wear contact lenses.
  • Subjects requiring chronic topical artificial tears, lubricants, and/or requiring any other chronic topical medications.
  • Subjects who have a history of chronic or recurrent inflammatory eye disease.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

1

2

3

Arm Description

Low Latanoprost-PPDS

Medium Latanoprost-PPDS

High Latanoprost-PPDS

Outcomes

Primary Outcome Measures

IOP change from baseline

Secondary Outcome Measures

Full Information

First Posted
March 27, 2008
Last Updated
September 16, 2013
Sponsor
Mati Therapeutics Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00650702
Brief Title
Safety and Efficacy of Punctum Plug Delivery System in Subjects With Open-Angle Glaucoma or Ocular Hypertension
Acronym
CORE
Official Title
A Phase II, Randomized, Masked, Parallel-Group Study of Safety and Preliminary Efficacy of the Punctum Plug Delivery System in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
March 2011
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
February 2009 (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 if the Punctum Plug Delivery System (PPDS) is safe and effective in controlling intraocular pressure in patients with open-angle glaucoma or ocular hypertension.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Ocular Hypertension
Keywords
glaucoma, ocular hypertension, IOP

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Low Latanoprost-PPDS
Arm Title
2
Arm Type
Experimental
Arm Description
Medium Latanoprost-PPDS
Arm Title
3
Arm Type
Experimental
Arm Description
High Latanoprost-PPDS
Intervention Type
Drug
Intervention Name(s)
Latanoprost-PPDS
Intervention Description
Control of IOP compared to baseline for the low dose of Latanoprost-PPDS for 4 months or until loss of efficacy
Intervention Type
Drug
Intervention Name(s)
Latanoprost-PPDS
Intervention Description
Control of IOP compared to baseline for the medium dose of Latanoprost-PPDS for 4 months or until loss of efficacy
Intervention Type
Drug
Intervention Name(s)
Latanoprost-PPDS
Intervention Description
Control of IOP compared to baseline for the high dose of Latanoprost-PPDS for 4 months or until loss of efficacy
Primary Outcome Measure Information:
Title
IOP change from baseline
Time Frame
12 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Over 18 yrs with open-angle glaucoma or ocular hypertension Subjects who have a best-corrected visual acuity of 20/100 or better. Exclusion Criteria: Uncontrolled medical conditions. Subjects who wear contact lenses. Subjects requiring chronic topical artificial tears, lubricants, and/or requiring any other chronic topical medications. Subjects who have a history of chronic or recurrent inflammatory eye disease.
Facility Information:
City
Artesia
State/Province
California
ZIP/Postal Code
90701
Country
United States
City
Sacramento
State/Province
California
ZIP/Postal Code
95815
Country
United States
City
Bel Air
State/Province
Maryland
ZIP/Postal Code
21014
Country
United States
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63131
Country
United States
City
Lynbrook
State/Province
New York
ZIP/Postal Code
11563
Country
United States
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19148
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Safety and Efficacy of Punctum Plug Delivery System in Subjects With Open-Angle Glaucoma or Ocular Hypertension

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