A PHASE II PROSPECTIVE RANDOMIZED DOUBLE-MASKED CROSSOVER STUDY ASSESSING THE SAFETY & EFFICACY OF RHPRG4 (450 μG/ML RECOMBINANT HUMAN PROTEOGLYCAN 4) COMPARED TO VEHICLE FOR THE TREATMENT OF OCULAR GRAFT-VERSUS-HOST DISEASE (OGVHD)
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;
• Have been stably using systemic medications for at least 14 days prior to Visit 1;
• VAS Eye Dryness (100-point scale) score ≥ 40 mm;
• Average VAS score for all symptoms of dry eye (dryness, foreign body sensation, burning/stinging, itching, pain, stick feeling, blurred vision and photophobia) ≥ 25 mm, none \< 5 mm;
• Have Oxford corneal fluorescein staining grade of ≥ 2 using the Oxford scale in the worst performing eye
• Stated willingness to comply with all study procedures, attend all scheduled clinic visits, and continue participation for the duration of the study;
⁃ Ability to self-administer study medication and willingness to adhere to the medication regimen.