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

Study Overview
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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.

Official Title
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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

Conditions
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Dry Eye Syndromes

Intervention / Treatment
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* Device: NDE L68 StableFit® Punctal Plug


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NDE L68 StableFit® punctal plug<br>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 | Device: NDE L68 StableFit® Punctal Plug<br>* 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.<br>* Other names: L-shaped Punctal Plug;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigators' Evaluation of the Tear Lake; Comparison of Baseline Result to 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 | 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 | Questionnaire | 28 days |