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

Completed · Not applicable

Conditions studied: Dry Eye Syndromes

In brief

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

Key facts

Study ID

NCT04280653

Run by

Mati Therapeutics Inc.

People needed

15

Starts

2019-08-28

Expected to finish

2019-12-11

Last updated by the study team

2020-12-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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