Predicting the Success of Dry Eye Disease Interventions Using Clinical Tests

• Status: Recruiting
• Trial end date: 2022-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tufts Medical Center
• Treatments: Lubricant Eye Drops; Ophthalmic Solutions

Criteria

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