Predicting the Success of Dry Eye Disease Interventions Using Clinical Tests

Launched by TUFTS MEDICAL CENTER · Oct 10, 2019

Keywords

ClinConnect Summary

This clinical trial is studying how well different tests can help predict which treatments will work for people with Dry Eye Disease (DED). The study involves 66 participants who are divided into two groups based on how they responded to a saline solution test. One group consists of individuals who showed some response or no change in their discomfort, while the other group includes those who experienced an increase in discomfort. To be eligible, participants must be at least 18 years old, have a diagnosis of DED with specific symptoms and signs, and meet certain criteria based on their response to the saline test.

Participants in the study will complete questionnaires and undergo various tests to evaluate their dry eye condition. Those who qualify will receive preservative-free artificial tears to use for four weeks, taking one drop in each eye twice a day. After this period, they will return for a follow-up appointment to answer the questionnaires again and repeat the tests. This trial aims to better understand how different indicators can help in managing and treating dry eye symptoms effectively.

Gender

ALL

Eligibility 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