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

Mati Therapeutics

Status: Completed

Conditions: Dry Eye Syndromes

Treatments: Device: NDE L68 StableFit® Punctal Plug

Study type: Interventional

Funder types: Industry

Identifiers

NCT04280653

NDE68-19-01

Details and patient eligibility

About

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

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

NDE L68 StableFit® punctal plug

Experimental group

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

Treatment:

Device: NDE L68 StableFit® Punctal Plug