Dry Eye Clinical Trial
Official title:
A Phase I/II Randomized, Placebo-controlled, Double-Blind, Single-Center, Tolerability and Preliminary Efficacy Clinical Trial of Intravenous Immunoglobulin (IVIG) Eye Drops in Patients With Dry Eye Disease
The main objective of this study is to establish whether patients with Dry Eye Disease are
able to safely tolerate receiving Intravenous Immunoglobulin (IVIG) eye drops two times a day
for eight weeks (primary 'safety and tolerability' objective). The exploratory objective is
to investigate the preliminary efficacy of the use of IVIG eye drops in treating Dry Eye
Disease (exploratory efficacy objective) to estimate the effectiveness of the trial
intervention and collecting data to inform the design of a future definitive trial.
This will be a Randomized controlled trial, in which a total of 28 subjects will be enrolled
at 1 clinical site. Subjects will be randomly assigned to one of two groups (#1, #2), with 14
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 (IVIG).
n/a
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