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Study of the Effects of Artificial Tears on the Response to the Latanoprost Punctal Plug Delivery System in Subjects With Ocular Hypertension or Open-Angle Glaucoma

Primary Purpose

Glaucoma, Ocular Hypertension

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Latanoprost punctal plug
artificial tears preserved with Benzalkonium Chloride
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

Eligibility Criteria

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

Inclusion Criteria:

  • Over 18 years 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
  • Uncontrolled medical conditions
  • Subjects with a known sensitivity to latanoprost, BAK, or any other products required for the study
  • Subjects requiring chronic topical artificial tears, lubricants, and/or requiring any other chronic topical medications.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

1

2

Arm Description

Latanoprost punctal plug and use of artificial tears containing Benzalkonium Chloride

Latanoprost punctal plug only

Outcomes

Primary Outcome Measures

IOP change from baseline

Secondary Outcome Measures

Full Information

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

Unique Protocol Identification Number
NCT00845299
Brief Title
Study of the Effects of Artificial Tears on the Response to the Latanoprost Punctal Plug Delivery System in Subjects With Ocular Hypertension or Open-Angle Glaucoma
Official Title
An Open-Label, Randomized, Phase 2 Study of the Effects of Artificial Tears Preserved With Benzalkonium Chloride (AT-BAK) on the Response to 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
January 2009 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 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 the effect of artificial tears preserved with Benzalkonium Chloride (AT-BAK) on the IOP response to the L-PPDS and to evaluate the safety of the L-PPDS in subjects with OH or OAG following treatment.

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Latanoprost punctal plug and use of artificial tears containing Benzalkonium Chloride
Arm Title
2
Arm Type
Experimental
Arm Description
Latanoprost punctal plug only
Intervention Type
Drug
Intervention Name(s)
Latanoprost punctal plug
Intervention Description
Control of IOP compared to baseline for the experimental dose of Latanoprost punctal plug for 6 weeks or until loss of efficacy.
Intervention Type
Drug
Intervention Name(s)
artificial tears preserved with Benzalkonium Chloride
Primary Outcome Measure Information:
Title
IOP change from baseline
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Over 18 years 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 Uncontrolled medical conditions Subjects with a known sensitivity to latanoprost, BAK, or any other products required for the study Subjects requiring chronic topical artificial tears, lubricants, and/or requiring any other chronic topical medications.
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

Study of the Effects of Artificial Tears on the Response to the Latanoprost Punctal Plug Delivery System in Subjects With Ocular Hypertension or Open-Angle Glaucoma

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