Status:
TERMINATED
Predicting the Success of Dry Eye Disease Interventions Using Clinical Tests
Lead Sponsor:
Tufts Medical Center
Conditions:
Dry Eye
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 H...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 3 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2025
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT04125134
Start Date
October 3 2019
End Date
July 31 2025
Last Update
September 22 2025
Active Locations (1)
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1
Tufts Medical Center-New England Eye Center
Boston, Massachusetts, United States, 02111