Safety and Efficacy of Punctal Plug Insertion in Patients With Dry Eye

Study Overview
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Brief Summary
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This study will access changes in tear protein levels and symptoms of dry eye following insertion of a punctal plug.

Conditions
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Dry Eye

Intervention / Treatment
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* Device: Punctal Plug


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with moderate to severe dry eye Exclusion Criteria: Previous punctal plug insertion in the last 3 months or presence of plugs at the time of study Contact lens wear in the 7 days prior to study start or during the study LASIK procedure in the last year Cataract or other eye surgery in the last 3 months Corneal grafts

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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No

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: Punctal plug<br>Punctal plugs inserted into the study eye on Day 1. | Device: Punctal Plug<br>* Punctal plugs inserted into the study eye on Day 1.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentration of Tear Cytokine Levels Before Punctal Plug Insertion in the Study Eye | A punctal plug (tear duct plug) is a device inserted into the tear duct (puncta) of the eye to block the tear duct from draining liquid from the eye. Tears were collected using the Schirmer's test strip. Tears are measured in the study eye for tear cytokine levels before punctal plug insertion in picogram(pg)/milliliter (mL)/millimeter (mm) of Schirmer's test strip moistened. Cytokines help with the generation of an immune response. Increased cytokine levels are representative of inflammation in the eye. | Week 0 (Baseline) | 
| Concentration of Tear Cytokine Levels Following Punctal Plug Insertion in the Study Eye | A punctal plug (tear duct plug) is a device inserted into the tear duct (puncta) of the eye to block the tear duct from draining liquid from the eye. Tears were collected using the Schirmer's test strip. Tears are measured in the study eye for tear cytokine levels before punctal plug insertion in picogram(pg)/milliliter (mL)/millimeter (mm) of Schirmer's test strip moistened. Cytokines help with the generation of an immune response. Increased cytokine levels are representative of inflammation in the eye. | Week 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Corneal Fluorescein Staining Score in the Study Eye | The cornea is evaluated following ocular administration of fluorescein stain in the study eye. The cornea is the transparent front part of the eye which covers the iris and pupil. The cornea is divided into 5 regions. Each region is scored according to the extent of staining, with scores ranging from 0 to 4 points: 0=non-staining to 4=regional whole staining of the cornea with 0.5 unit intervals. The higher the staining score, the worse the dry eye condition. | Week 0 (Baseline), Week 3 | 
| Tear Film Break-up Time (TBUT) | TBUT is defined as the time to initial breakup of the tear film following a blink. The longer it takes, the more stable the tear film. | Week 0 (Baseline), Week 3 | 
| Schirmer's Test Score | The Schirmer's Test measures the rate of tear secretion by the eye over 5 minutes (min). The results indicate the presence of dry eye (Normal = greater than or equal to 10 millimeters (mm) of tears, Dry Eye = less than 10 mm of tears). The smaller the number, the more severe the dry eye. | Week 0 (Baseline), Week 3 | 
| Dry Eye Questionnaire Irritation Score | Severity of dry eye irritation is rated by the patient using a visual analogue scale (VAS). Patients put a mark on a 100 millimeter line where 0 (far left on the line)=no symptoms to 100 (far right on the line)=most severe symptoms. The higher the score, the more severe the symptoms. | Week 0 (Baseline), Week 3 |