NCT04125134

Predicting the Success of Dry Eye Disease Interventions Using Clinical Tests

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Tufts Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	Preservative-free Refresh Optive Advanced Lubricant Eye Drops	over the counter artificial tear

Timeline

• Start date: 2019-10-03
• Primary completion: 2024-10-11
• Completion: 2025-07-31
• First posted: 2019-10-14
• Last updated: 2025-09-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study