The Utility of IVCM to Assess Cellular Response and Efficacy of Long-term Topical Steroid Treatment in Patients With DED
Status:
Completed
Trial end date:
2018-01-28
Target enrollment:
Participant gender:
Summary
This research study is looking to see if in vivo confocal microscopy (IVCM) imaging can be
used to confirm clinical findings (which are noted by the doctor during an eye exam) and
measure the immune response to the inflammation in the subject's cornea (the front part of
the eyeball).
Additionally, this study is trying to determine the effectiveness of two eye-drops, Lotemax
and artificial tears, in treating the inflammation associated with DED by measuring changes
in immune cells with IVCM imaging. The subject will be treated with either Lotemax
(loteprednol) or artificial tears (a lubricating eye drop with no medication). Lotemax is an
FDA-approved steroid eye-drop that is often used to treat inflammation associated with DED.
Artificial tears are approved by the FDA for treatment of dryness associated with DED.
Thus, this study is designed to determine the effects of the administration of a topical
steroid, Lotemax, over a treatment period of 6 weeks, using novel methods of detecting
efficacy. In order to achieve the aforementioned goal, subjects will be prospectively
randomized to one of two treatment arms - Lotemax or artificial tear. Both groups will follow
the same study schedule.
Phase:
Phase 4
Details
Lead Sponsor:
Massachusetts Eye and Ear Infirmary Tufts Medical Center