The Retention Rate Between Brand A and Brand B Punctal Plugs

Study Overview
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Brief Summary
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The purpose of this study is to determine if Parasol punctal occluders (Brand A) have a higher rate of retention than Superflex punctal plugs (Brand B).

Detailed Description
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Eyes will be randomized to either Brand A or Brand B punctal plug. The primary outcome measure is length of time punctual plugs are retained, measured in months. This will be measured at monthly assessments for 6 months. Secondary outcome measures include patient satisfaction, and improvement in subjective and objective dry eye scores, as well as complications related to punctual plugs including spontaneous plug loss, and intolerance. We will evaluate these measures by repeating the Canadian Dry Eye Assessment, Schirmer 1, tear meniscus height, fluorescein corneal staining (NEI scale), and lissamine green conjunctival staining (NEI scale) at month 1, month 3, and month 6 visits.

Official Title
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The Retention Rate Between Superflex Punctal Plugs, and Parasol Punctal Occluders

Conditions
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Dry Eye

Intervention / Treatment
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* Device: Parasol Punctal Occluder
* Device: Superflex Punctal Occluder


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: moderate dry eye, severe dry eye Exclusion Criteria: silicone allergy, punctal stenosis, punctal occlusion, punctal cautery
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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Parasol Punctal Occluder Group<br>Randomized to receive Brand A punctal plugs | Device: Parasol Punctal Occluder<br>* Patients will be randomized to receive one of these 2 punctal occluders in the management of dry eyes.<br>|
| Superflex Punctal Occluder Group<br>Randomized to receive Group B punctal plugs | Device: Superflex Punctal Occluder<br>* Patients will be randomized to receive one of these 2 punctal occluders in the management of dry eyes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of Retention |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Canadian Dry Eye Assessment Score | Describes the scores on a scale and range from 0-3. Higher score represents more severe dry eye. Score 0 = no dry eye symptoms, score 1 = mild dry eye symptoms, score 2 = moderate dry eye symptoms, score 3 = severe dry eye symptoms. | 6 months | 
| National Eye Institute Corneal Fluorescein Staining Pattern | The cornea is divided into 5 zones, and the inferior zone 5 was assessed for staining pattern. Grade 0= no staining, grade 1= trace staining, grade 2= mild staining, grade 3= moderate staining, and grade 4= severe staining. | 6 months | 
| National Eye Institute Grading for Conjunctival Staining | The conjunctival staining is divided into 6 zones. Each zone received a score for staining with lissamine green. Grade 0= no staining, grade 1= trace staining, grade 2= mild staining, grade 3= moderate staining, grade 4= severe staining. Data from different zones was combined and the total value was averaged. | 6 months | 
| Tear Meniscus Height | Meniscus height measured in mm | 6 months |