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A Study of Different Formulations of the L-PPDS in Subjects With OH or OAG

Primary Purpose

Glaucoma, Ocular Hypertension

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Formulation E1 of L-PPDS
Formulation E2 of L-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:

  • Subjects over 18 years of age diagnosed with ocular hypertension or open-angle glaucoma
  • Subjects who have a best corrected visual acuity of 20/100 or better

Exclusion Criteria:

  • Subjects who wear contact lenses
  • Subjects who have uncontrolled medical conditions
  • Subjects requiring chronic topical artificial tears, lubricants, and/or requiring any other chronic ocular 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 Type

Experimental

Experimental

Arm Label

1. Formulation E1

2. Formulation E2

Arm Description

Formulation E1 of Latanoprost-PPDS

Formulation E2 of Latanoprost-PPDS

Outcomes

Primary Outcome Measures

IOP change from baseline

Secondary Outcome Measures

Full Information

First Posted
August 27, 2009
Last Updated
September 16, 2013
Sponsor
Mati Therapeutics Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00967811
Brief Title
A Study of Different Formulations of the L-PPDS in Subjects With OH or OAG
Official Title
An Open-Label, Phase 2 Study of Different Formulations (E1 and E2) 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
August 2009 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (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 safety and preliminary efficacy of two formulations of the Latanoprost-PPDS 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
Glaucoma, Ocular Hypertension

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
1. Formulation E1
Arm Type
Experimental
Arm Description
Formulation E1 of Latanoprost-PPDS
Arm Title
2. Formulation E2
Arm Type
Experimental
Arm Description
Formulation E2 of Latanoprost-PPDS
Intervention Type
Drug
Intervention Name(s)
Formulation E1 of L-PPDS
Intervention Description
Control of IOP compared to baseline for Formulation E1 of the experimental dose of Latanoprost-PPDS for 6 weeks or until loss of efficacy.
Intervention Type
Drug
Intervention Name(s)
Formulation E2 of L-PPDS
Intervention Description
Control of IOP compared to baseline for Formulation E2 of experimental dose of Latanoprost-PPDS for 6 weeks 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: Subjects over 18 years of age diagnosed with ocular hypertension or open-angle glaucoma Subjects who have a best corrected visual acuity of 20/100 or better Exclusion Criteria: Subjects who wear contact lenses Subjects who have uncontrolled medical conditions Subjects requiring chronic topical artificial tears, lubricants, and/or requiring any other chronic ocular topical medications Subjects who have a history of chronic or recurrent inflammatory eye disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oscar Cuzzani, MD
Organizational Affiliation
QLT Inc.
Official's Role
Study Director
Facility Information:
City
Menlo Park
State/Province
California
ZIP/Postal Code
94025
Country
United States

12. IPD Sharing Statement

Learn more about this trial

A Study of Different Formulations of the L-PPDS in Subjects With OH or OAG

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