Predicting the Success of Dry Eye Disease Interventions Using Clinical Tests
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.
∙ 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