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PreDICT


Title Predicting the Success of Dry Eye Disease Treatment Using Hyperosmolarity Drops
Therapeutic Area Dry Eye
Principal Investigator Stephanie Cox, DO
Min Age 18 Years
Gender Any
Contact Bethany Saul, Michael Dixon
617-636-1050, 617-636-1051
bsaul@tuftsmedicalcenter.org, mdixon3@tuftsmedicalcenter.org

Overview

This is a single site, prospective, cross-sectional, controlled clinical study on a total of 66 subjects. The subjects are divided into two groups: HS non-responders (33 subjects) and HS responders (33 subjects). After completion of questionnaires, the subjects will undergo DED 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 DED tests and functional nerve tests will be repeated.

Study Details

Inclusion Criteria

  • Diagnosis of Dry Eye Disease Anesthetized
  • Schirmer test of <10 mm over 5 minutes
  • Tear break-up time (TBUT) of ≤5 seconds

Exclusion Criteria

  • Unable to complete questionnaires in English
  • History of ocular surgery, corneal infection, or corneal injury within the last 3 months
  • Changes in topical or systemic medications in the last 3 months or anticipated changes in medication during the course of treatment

Study Requirements

After completion of questionnaires, the subjects will undergo DED 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 DED tests and functional nerve tests will be repeated.