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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

NCT ID: NCT04280653

Last Updated: 2020-12-08

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-28

Study Completion Date

2019-12-11

Brief Summary

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To evaluate the effect of the NDE L68 StableFit® punctal plug on the tear lake.

Detailed Description

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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.

Conditions

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Dry Eye Syndromes

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

NDE L68 StableFit® Punctal Plug

Intervention Type DEVICE

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.

Interventions

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NDE L68 StableFit® Punctal Plug

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.

Intervention Type DEVICE

Other Intervention Names

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L-shaped Punctal Plug

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mati Therapeutics Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Cincinnati Eye Institute-Edgewood

Edgewood, Kentucky, United States

Site Status

Ophthalmic Consultants of Long Island

Garden City, New York, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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NDE68-19-01

Identifier Type: -

Identifier Source: org_study_id