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Predicting the Success of Dry Eye Disease Interventions Using Clinical Tests

NCT04125134 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2025-09-22

No results posted yet for this study

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.

Conditions

  • Dry Eye

Interventions

DRUG

Preservative-free Refresh Optive Advanced Lubricant Eye Drops

over the counter artificial tear

Sponsors & Collaborators

  • Tufts Medical Center

    lead OTHER

Principal Investigators

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

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-03
Primary Completion
2024-10-11
Completion
2025-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04125134 on ClinicalTrials.gov