The main objective of this study is to assess the clinical and mechanistic effect of using
Ocular surface immunoglobulin (OSIG) eye drops for treating Dry Eye Disease. Therefore, the
investigator will perform a prospective, phase II, randomized, placebo-controlled,
double-masked, tolerability and efficacy clinical trial using OSIG-eye drops in patients with
Dry Eye Disease. This clinical trial will be powered to detect efficacy of the treatment.
This will be a Randomized controlled trial, in which a total of 40 subjects will be enrolled
at one clinical site. Subjects will be randomly assigned to one of two groups (#1, #2), with
20 subjects per group. One group will be given placebo (Normal saline eye drops) and the
other group will be given eye drops containing the study drug (OSIG). Treatment will be for
eight weeks.
Phase:
Phase 2
Details
Lead Sponsor:
Sandeep Jain, MD University of Illinois at Chicago