Status:
COMPLETED
An Open-Label, Multi-Center, Clinical Study Evaluating the Effect of the NDE L68 StableFit® Punctal Plug on the Tear Lake
Lead Sponsor:
Mati Therapeutics Inc.
Conditions:
Dry Eye Syndromes
Eligibility:
All Genders
18+ years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 28 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 11 2019
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04280653
Start Date
August 28 2019
End Date
December 11 2019
Last Update
December 8 2020
Active Locations (2)
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1
Cincinnati Eye Institute-Edgewood
Edgewood, Kentucky, United States, 41017
2
Ophthalmic Consultants of Long Island
Garden City, New York, United States, 11530