NCT02120079View on ClinicalTrials.gov

The Utility of IVCM to Assess Cellular Response and Efficacy of Long-term Topical Steroid Treatment in Patients With DED

PHASE4CompletedINTERVENTIONAL
Enrollment

37

Participants

Timeline

Start Date

February 28, 2014

Primary Completion Date

April 30, 2017

Study Completion Date

January 28, 2018

Conditions
Dry Eye Disease
Interventions
DRUG

Lotemax

Lotemax (loteprednol etabonate) 0.5% will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks.

DRUG

Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears)

Soothe Tired Eyes Lubricant Eye Drop will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks.

DIAGNOSTIC_TEST

In Vivo Confocal Microscopy (IVCM)

In vivo confocal microscopy (IVCM) is a new imaging method, which allows visualization of the corneal structures at the cellular level. With a magnification of 800 times, it makes it possible to detect and quantify changes in the epithelial layers and sub-basal nerve plexus.

Trial Locations (1)

02111

Tufts Medical Center, Boston

All Listed Sponsors
lead

Tufts Medical Center

OTHER

NCT02120079 - The Utility of IVCM to Assess Cellular Response and Efficacy of Long-term Topical Steroid Treatment in Patients With DED | Biotech Hunter | Biotech Hunter