Mucin Levels in Dry Eye and Normal Populations

Study Overview
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Brief Summary
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The purpose of this study is to evaluate changes in ocular mucin levels in response to a drying environment in subjects with dry eye disease as well as patients who report no history of dry eye disease. It is expected that exposure to the dry environment will alter mucin levels in different ways when comparing the two groups.

Detailed Description
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This is a single-center, two visit, pilot, drying environment study (CAE). There will be two different groups of subjects enrolled into this study: dry eye subjects and subjects with no prior diagnosis of dry eye. All subjects will undergo safety and dry eye assessments as well as tear collection prior to and after being exposed to a dry environment. They will also return the following day to undergo dry eye assessments, tear collection, and safety procedures again.

Official Title
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A Single-Center Pilot Study To Evaluate the Effects of a Challenge Model on Mucin 16 Levels in Dry Eye Subjects Compared to Normal Subjects

Conditions
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Dry Eye

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be male or female of any race, at least 18 years of age at Visit 1. Have provided verbal and written informed consent. Have a best corrected visual acuity of +0.70 logMAR or better in both eyes at Visit 1, as assessed by Early Treatment of Diabetic Retinopathy Study (ETDRS) chart. If a woman of childbearing potential, have a negative urine pregnancy test at Visit 1 and agree to use a medically acceptable form of birth control throughout the study duration . [Females are considered of childbearing potential unless they are surgically sterilized (bilateral tubal ligation, hysterectomy or bilateral oophorectomy) or post-menopausal (at least 12 months since last menses).] Have previously completed a recent trial OR not completed a recent trial AND report no symptoms of dry eye disease. Exclusion Criteria: Have planned surgery during trial period Female currently pregnant, planning a pregnancy or lactating Use of disallowed medications Have ocular infections, or ocular conditions that could affect study parameters Have used an investigational drug or device within 30 days of start of study Female that is currently pregnant, planning a pregnancy or lactating

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Non-Dry Eye Subjects<br>Subjects with no reported history of dry eye disease will be enrolled | |
| Dry Eye Disease<br>Subjects who have been diagnosed with dry eye disease in a previous trial will be enrolled. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mucin levels assayed from collected tears | Tears will be collected and mucin will be measured after subjects are exposed to the CAE. | 10-30 minutes Post CAE at Visit 1 | 
| Mucin levels assayed from collected tears | Tears will be collected and mucin will be measured 24 hours after being exposed to the CAE. | 24 hours after being exposed to the CAE | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fluorescein staining | staining will be measured to detect presence of Superficial Punctate Keratitis and Confluency using Ora Calibra™ Corneal and Conjunctival Staining Scales | pre-CAE | 
| Fluorescein staining | Staining will be measured to detect presence of Superficial Punctate Keratitis and Confluency using Ora Calibra™ Corneal and Conjunctival Staining Scales | 10-30 minutes Post CAE | 
| Fluorescein staining | Staining will be measured measured to detect presence of Superficial Punctate Keratitis and Confluency using Ora Calibra™ Corneal and Conjunctival Staining Scales | 24 hours post-CAE | 
| Lissamine staining | Staining will be measured to detect presence of Superficial Punctate Keratitis and Confluency using Ora Calibra™ Corneal and Conjunctival Staining Scales | pre-CAE | 
| Lissamine staining | Staining will be measured to detect presence of Superficial Punctate Keratitis and Confluency using Ora Calibra™ Corneal and Conjunctival Staining Scales | 10-30 minutes Post CAE | 
| Lissamine staining | Staining will be measured to detect presence of Superficial Punctate Keratitis and Confluency using Ora Calibra™ Corneal and Conjunctival Staining Scales | 24 hours post-CAE | 
| Presence of conjunctival redness | conjunctival redness will be assessed by Ora Calibra™ Conjunctival Redness Scale | pre-CAE | 
| Presence of conjunctival redness | conjunctival redness will be assessed by Ora Calibra™ Conjunctival Redness Scale | 10-30 minutes Post CAE | 
| Presence of conjunctival redness | conjunctival redness will be assessed by Ora Calibra™ Conjunctival Redness Scale | 24 hours post-CAE | 
| Tear Film Break Up Time | Tear Film Break Up Time | pre-CAE | 
| Tear Film Break Up Time | Tear Film Break Up Time | 10-30 minutes Post CAE | 
| Tear Film Break Up Time | Tear Film Break Up Time | 24 hours post-CAE | 
| Blink Rate Analysis | Blink Rate Analysis | pre-CAE | 
| Blink Rate Analysis | Blink Rate Analysis | 10-30 minutes Post CAE | 
| Blink Rate Analysis | Blink Rate Analysis | 24 hours post-CAE | 
| Symptom Collection | Symptom Collection | pre-CAE | 
| Symptom Collection | Symptom Collection | 10-30 minutes Post CAE | 
| Symptom Collection | Symptom Collection | 24 hours post-CAE | 
| Ora Calibra Ocular Protection Index 2.0 | Ora Calibra Ocular Protection Index 2.0 | pre-CAE | 
| Ora Calibra Ocular Protection Index 2.0 | Ora Calibra Ocular Protection Index 2.0 | 10-30 minutes Post CAE | 
| Ora Calibra Ocular Protection Index 2.0 | Ora Calibra Ocular Protection Index 2.0 | 24 hours post-CAE | 
| Schirmer's Test | Schirmer's Test | End of Visit 2 (Day 1 of study) |