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An Open-Label, Multi-Center, Clinical Study Evaluating the Effect of the NDE L68 StableFit® Punctal Plug on the Tear Lake

Primary Purpose

Dry Eye Syndromes

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
NDE L68 StableFit® Punctal Plug
Sponsored by
Mati Therapeutics Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye Syndromes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. A male or female subject, 18 years of age or older, in good general health at the time of the baseline examination, who may or may not have a mild to moderate dry eye condition
  2. A subject must be able to read, comprehend and be willing to give HIPAA authorization and informed consent
  3. A subject must be willing to have a punctal plug inserted in the lower punctum of one of their eyes
  4. A subject must be willing to comply with all study instructions, agree to make all office appointments, and complete the entire course of the study

Exclusion Criteria:

  1. A subject with a history of complications, adverse events, trauma or disease in the nasolacrimal area, whether or not it was due to punctal plug wear, including but not limited to dacryocystitis, inflammation or canaliculitis in the planned study eye
  2. A subject with a history of intolerance to punctal plugs
  3. A subject with structural lid abnormalities (e.g., ectropion, entropion) in the planned study eye
  4. A subject with any clinically significant lid, conjunctival or corneal findings in the planned study eye at the baseline visit
  5. A subject with a severe dry eye condition
  6. A subject experiencing epiphora in the planned study eye
  7. A subject experiencing any clinically significant ocular pain or discomfort in or around either eye at the baseline visit

Sites / Locations

  • Cincinnati Eye Institute-Edgewood
  • Ophthalmic Consultants of Long Island

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

NDE L68 StableFit® punctal plug

Arm Description

Each study subject that qualifies at the baseline visit will receive an NDE L68 StableFit® punctal plug in the lower punctum in one of their eyes. All study plugs will remain in the study subject's lower punctum for a period of 28 + 4 days after insertion

Outcomes

Primary Outcome Measures

Investigators' Evaluation of the Tear Lake; Comparison of Baseline Result to 7 Days
The primary study endpoint will be the comparison of the tear lake volume at baseline with the tear lake volume at each follow-up visit. The tear lake will be evaluated using a slit lamp micrometer, the micrometer will be oriented vertically and centered on the lower lid margin at the middle of the lower lid. The tear lake will be measured using the slit lamp micrometer from the lid margin to the superior border of the lower tear lake and measured to 0.1 mm. The average mean percent change from baseline tear lake volume was compared to that at 7 days.
Investigators' Evaluation of the Tear Lake; Comparison of Baseline Result to 28 Days
The primary study endpoint will be the comparison of the tear lake volume at baseline with the tear lake volume at each follow-up visit. The tear lake will be evaluated using a slit lamp micrometer, the micrometer will be oriented vertically and centered on the lower lid margin at the middle of the lower lid. The tear lake will be measured using the slit lamp micrometer from the lid margin to the superior border of the lower tear lake and measured to 0.1 mm. The average mean percent change from baseline tear lake volume was compared to that at 28 days.

Secondary Outcome Measures

Investigator's Evaluation \ of the Subject's Acceptance of the NDE L68 StableFit® Punctal Plug, Comparison of Baseline Result to 28 Days
Questionnaire

Full Information

First Posted
January 31, 2020
Last Updated
December 3, 2020
Sponsor
Mati Therapeutics Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04280653
Brief Title
An Open-Label, Multi-Center, Clinical Study Evaluating the Effect of the NDE L68 StableFit® Punctal Plug on the Tear Lake
Official Title
An Open-Label, Multi-Center, Clinical Study Evaluating the Effect of the NDE L68 StableFit® Punctal Plug on the Tear Lake
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
August 28, 2019 (Actual)
Primary Completion Date
December 11, 2019 (Actual)
Study Completion Date
December 11, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mati Therapeutics Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
To evaluate the effect of the NDE L68 StableFit® punctal plug on the tear lake.
Detailed Description
This is a Non-Significant Risk (NSR) medical device, multi-center, open-label clinical study. Each study subject that qualifies at the baseline visit will receive an NDE L68 StableFit® punctal plug in the lower punctum in one of their eyes. All study plugs will remain in the study subject's lower punctum for a period of 28 + 4 days after insertion.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndromes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NDE L68 StableFit® punctal plug
Arm Type
Experimental
Arm Description
Each study subject that qualifies at the baseline visit will receive an NDE L68 StableFit® punctal plug in the lower punctum in one of their eyes. All study plugs will remain in the study subject's lower punctum for a period of 28 + 4 days after insertion
Intervention Type
Device
Intervention Name(s)
NDE L68 StableFit® Punctal Plug
Other Intervention Name(s)
L-shaped Punctal Plug
Intervention Description
Tear lake evaluation of the planned study eye, prior to insertion of the Punctal Plug and then tear lake evaluation at days 7 and 28 after punctal plug insertion.
Primary Outcome Measure Information:
Title
Investigators' Evaluation of the Tear Lake; Comparison of Baseline Result to 7 Days
Description
The primary study endpoint will be the comparison of the tear lake volume at baseline with the tear lake volume at each follow-up visit. The tear lake will be evaluated using a slit lamp micrometer, the micrometer will be oriented vertically and centered on the lower lid margin at the middle of the lower lid. The tear lake will be measured using the slit lamp micrometer from the lid margin to the superior border of the lower tear lake and measured to 0.1 mm. The average mean percent change from baseline tear lake volume was compared to that at 7 days.
Time Frame
7 days
Title
Investigators' Evaluation of the Tear Lake; Comparison of Baseline Result to 28 Days
Description
The primary study endpoint will be the comparison of the tear lake volume at baseline with the tear lake volume at each follow-up visit. The tear lake will be evaluated using a slit lamp micrometer, the micrometer will be oriented vertically and centered on the lower lid margin at the middle of the lower lid. The tear lake will be measured using the slit lamp micrometer from the lid margin to the superior border of the lower tear lake and measured to 0.1 mm. The average mean percent change from baseline tear lake volume was compared to that at 28 days.
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Investigator's Evaluation \ of the Subject's Acceptance of the NDE L68 StableFit® Punctal Plug, Comparison of Baseline Result to 28 Days
Description
Questionnaire
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: A male or female subject, 18 years of age or older, in good general health at the time of the baseline examination, who may or may not have a mild to moderate dry eye condition A subject must be able to read, comprehend and be willing to give HIPAA authorization and informed consent A subject must be willing to have a punctal plug inserted in the lower punctum of one of their eyes A subject must be willing to comply with all study instructions, agree to make all office appointments, and complete the entire course of the study Exclusion Criteria: A subject with a history of complications, adverse events, trauma or disease in the nasolacrimal area, whether or not it was due to punctal plug wear, including but not limited to dacryocystitis, inflammation or canaliculitis in the planned study eye A subject with a history of intolerance to punctal plugs A subject with structural lid abnormalities (e.g., ectropion, entropion) in the planned study eye A subject with any clinically significant lid, conjunctival or corneal findings in the planned study eye at the baseline visit A subject with a severe dry eye condition A subject experiencing epiphora in the planned study eye A subject experiencing any clinically significant ocular pain or discomfort in or around either eye at the baseline visit
Facility Information:
Facility Name
Cincinnati Eye Institute-Edgewood
City
Edgewood
State/Province
Kentucky
ZIP/Postal Code
41017
Country
United States
Facility Name
Ophthalmic Consultants of Long Island
City
Garden City
State/Province
New York
ZIP/Postal Code
11530
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

An Open-Label, Multi-Center, Clinical Study Evaluating the Effect of the NDE L68 StableFit® Punctal Plug on the Tear Lake

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