An 84-day, prospective, randomized (1:1) vehicle controlled, double-masked pre-market, crossover study. Subjects with moderate to severe oGVHD related Dry Eye Disease Each subject will receive both treatments in random sequence, each for 28 days, separated by a 14-day vehicle washout period.
Have the ability to comprehend and provide a signed and dated consent form.
Are 18-80 years of age at time of consent;
Have been diagnosed with oGVHD for at least 3 months prior to giving informed consent to participate in the trial;
Current use of artificial tears for the treatment of oGVHD related dry eye;
are currently pregnant or,
have a positive result on the urine pregnancy test at the Screening/Baseline Visit or,
intend to become pregnant during the entire course of and 30 days after the study treatment periods, or,
are breast-feeding or,