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

December 3, 2020 updated by: Mati Therapeutics Inc.
To evaluate the effect of the NDE L68 StableFit® punctal plug on the tear lake.

Study Overview

Status

Completed

Conditions

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.

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Kentucky
      • Edgewood, Kentucky, United States, 41017
        • Cincinnati Eye Institute-Edgewood
    • New York
      • Garden City, New York, United States, 11530
        • Ophthalmic Consultants of Long Island

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: NDE L68 StableFit® punctal plug
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
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.
Other Names:
  • L-shaped Punctal Plug

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Investigators' Evaluation of the Tear Lake; Comparison of Baseline Result to 7 Days
Time Frame: 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.

7 days
Investigators' Evaluation of the Tear Lake; Comparison of Baseline Result to 28 Days
Time Frame: 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.

28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Investigator's Evaluation \ of the Subject's Acceptance of the NDE L68 StableFit® Punctal Plug, Comparison of Baseline Result to 28 Days
Time Frame: 28 days
Questionnaire
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 28, 2019

Primary Completion (ACTUAL)

December 11, 2019

Study Completion (ACTUAL)

December 11, 2019

Study Registration Dates

First Submitted

January 31, 2020

First Submitted That Met QC Criteria

February 19, 2020

First Posted (ACTUAL)

February 21, 2020

Study Record Updates

Last Update Posted (ACTUAL)

December 8, 2020

Last Update Submitted That Met QC Criteria

December 3, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • NDE68-19-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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