TERMINATED

Predicting the Success of Dry Eye Disease Interventions Using Clinical Tests

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Predicting the Success of Dry Eye Disease Interventions Using Clinical Tests

Quick Facts

Study Start:2019-10-03
Study Completion:2025-07-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:TERMINATED

Study ID

NCT04125134

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * At least 18 years of age
  2. * Ability to consent
  3. * Diagnosis of Dry Eye Disease (DED) based on:
  4. * Symptoms of DED, shown with SANDE score of 50mm or greater
  5. * 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
  6. * HS response result of one of the following:
  7. * Reduction of discomfort/pain rating
  8. * No change of discomfort/pain rating
  9. * Increase in discomfort/pain rating score of 1 step or less
  10. * At least 18 years of age
  11. * Ability to consent
  12. * Diagnosis of DED based on:
  13. * Symptoms of DED, shown with SANDE score 50mm or greater
  14. * 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
  15. * HS response result of an increase in discomfort/pain rating of greater than 1 step
  1. * Presence of centralized pain as indicated by a proparacaine challenge test (PCT) of less than 50% ocular surface discomfort reduction
  2. * Unable to speak English
  3. * History of ocular surgery, corneal infection, or corneal injury within the last 3 months
  4. * Active ocular allergies or other condition that could impact the study results
  5. * Allergic to benzalkonium chloride "BAK" (an eye-drop preservative)
  6. * Changes in topical or systemic medications in the last 3 months or anticipated changes in medication during the course of treatment
  7. * Use of other topical treatments
  8. * Concurrent enrollment in other studies that in the opinion of the investigator will interfere with the results of this study
  9. * Use of contact lenses within the last month

Contacts and Locations

Principal Investigator

Stephanie Cox, OD
PRINCIPAL_INVESTIGATOR
Tufts Medical Center New England Eye Center

Study Locations (Sites)

Tufts Medical Center-New England Eye Center
Boston, Massachusetts, 02111
United States

Collaborators and Investigators

Sponsor: Tufts Medical Center

  • Stephanie Cox, OD, PRINCIPAL_INVESTIGATOR, Tufts Medical Center New England Eye Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-10-03
Study Completion Date2025-07-31

Study Record Updates

Study Start Date2019-10-03
Study Completion Date2025-07-31

Terms related to this study

Keywords Provided by Researchers

  • Dry Eye
  • artifical tear

Additional Relevant MeSH Terms

  • Dry Eye