Predicting the Success of Dry Eye Disease Interventions Using Clinical Tests

Study Overview
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Brief Summary
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This is a single site, prospective, cross-sectional, controlled clinical study on a total of 66 subjects. The subjects are divided into two groups: Hypertonic Saline Non-Responders (33 subjects) and Hypertonic Saline Responders (33 subjects). After completion of questionnaires, the subjects will undergo Dry Eye Disease testing and functional nerve testing. Subjects who qualify will be dispensed 4 weeks of preservative free artificial tears and instructed to instill one drop into each eye twice daily. Subjects will return for a follow up visit 4 weeks later (± 4 days), during which subjects will complete the questionnaires again and the Dry Eye Disease tests and functional nerve tests will be repeated.

Official Title
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Predicting the Success of Dry Eye Disease Interventions Using Clinical Tests

Conditions
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Dry Eye

Intervention / Treatment
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* Drug: Preservative-free Refresh Optive Advanced Lubricant Eye Drops


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Group 1 (Hypertonic saline non-responders): At least 18 years of age Ability to consent Diagnosis of Dry Eye Disease (DED) based on: Symptoms of DED, shown with SANDE score of 50mm or greater Two or more of the following objective signs in the same eye: 1. Schirmer test of 10 mm or less over 5 minutes; 2. Fluorescein tear break-up time (FTBUT) of 7 seconds or less; 3. Meibomian gland expression (MGE) grade of 2 or greater for at least 3 out of 5 glands HS response result of one of the following: Reduction of discomfort/pain rating No change of discomfort/pain rating Increase in discomfort/pain rating score of 1 step or less Group 2 (Hypertonic saline non-responders): At least 18 years of age Ability to consent Diagnosis of DED based on: Symptoms of DED, shown with SANDE score 50mm or greater Two or more of the following objective signs in the same eye: 1. Schirmer test of 10 mm or less over 5 minutes; 2. Fluorescein tear break-up time (FTBUT) of 7 seconds or less; 3. Meibomian gland expression (MGE) grade of 2 or greater for at least 3 out of 5 glands HS response result of an increase in discomfort/pain rating of greater than 1 step Exclusion Criteria: Presence of centralized pain as indicated by a proparacaine challenge test (PCT) of less than 50% ocular surface discomfort reduction Unable to speak English History of ocular surgery, corneal infection, or corneal injury within the last 3 months Active ocular allergies or other condition that could impact the study results Allergic to benzalkonium chloride BAK (an eye-drop preservative) Changes in topical or systemic medications in the last 3 months or anticipated changes in medication during the course of treatment Use of other topical treatments Concurrent enrollment in other studies that in the opinion of the investigator will interfere with the results of this study Use of contact lenses within the last month

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: Other
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hypertonic Saline Responders<br>Subjects who qualify as hypertonic saline responders will be instructed to instill 1-2 drops of preservative-free Refresh Optive Advanced Lubricant Eye Drops, which are available over the counter, into each eye twice a day for 28 days. | Drug: Preservative-free Refresh Optive Advanced Lubricant Eye Drops<br>* over the counter artificial tear<br>|
| Experimental: Hypertonic Saline Non-responders<br>Subjects who qualify as hypertonic saline non-responders will be dispensed the same instructions and treatment as the Hypertonic Saline Responders. They will be instructed to instill 1-2 drops of preservative-free Refresh Optive Advanced Lubricant Eye Drops, which are available over the counter, into each eye twice a day for 28 days. | Drug: Preservative-free Refresh Optive Advanced Lubricant Eye Drops<br>* over the counter artificial tear<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in SANDE severity score response from visit 1 to visit 2 | The SANDE questionnaire is a paper and pencil questionnaire consisting of two questions (1. severity of dry eye disease symptoms and 2. frequency of dry eye disease symptoms), which are answered on a continuous visual analogue scale. The severity response from visit 2 will be subtracted from that given in visit 1 to provide a subject change. The results of those in the hypertonic saline response group will be compared to those within the hypertonic non-response group. | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in tear break up time from visit 1 to visit 2 | The tear break up time is a measure of the stability of the tear film. The measurement from visit 2 will be subtracted from that given in visit 1 to provide a subject change. The results of those in the hypertonic saline response group will be compared to those within the hypertonic non-response group. | 4 weeks | 
| Change in Schirmer test from visit 1 to visit 2 | The Schirmer test is a measure of tear production. The measurement from visit 2 will be subtracted from that given in visit 1 to provide a subject change. The results of those in the hypertonic saline response group will be compared to those within the hypertonic non-response group. | 4 weeks | 
| Change in meibomian gland expression from visit 1 to visit 2 | Meibomian gland expression allows for a measure of the health of the meibomian glands. The measurement from visit 2 will be subtracted from that given in visit 1 to provide a subject change. The results of those in the hypertonic saline response group will be compared to those within the hypertonic non-response group. | 4 weeks | 
| Change in proparacaine challenge test from visit 1 to visit 2 | The proparacaine challenge test allows for a measure of the amount of peripheral neuropathic pain compared to centralized neuropathic pain. The measurement from visit 2 will be subtracted from that given in visit 1 to provide a subject change. The results of those in the hypertonic saline response group will be compared to those within the hypertonic non-response group. | 4 weeks | 
| Change in hypertonic saline response test from visit 1 to visit 2 | The hypertonic saline response is expected to be able to assess the severity of dry eye disease. The measurement from visit 2 will be subtracted from that given in visit 1 to provide a subject change. The results of those in the hypertonic saline response group will be compared to those within the hypertonic non-response group. | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dry Eye, artifical tear