Study of d-MAPPS™ Ophthalmic Solution, Safety, Tolerability, and Efficacy in the Treatment of Chronic Ocular Graft-Versus-Host Disease (oGVHD)

A Double-Masked, Randomized, Placebo-Controlled Study of the Safety, Tolerability, and Efficacy of d-MAPPS™ Ophthalmic Solution in the Treatment of Chronic Ocular Graft-Versus-Host Disease (oGVHD)

A Double-Masked, Randomized, Placebo-Controlled Study of the Safety, Tolerability, and Efficacy of d-MAPPS™ Ophthalmic Solution in the Treatment of Chronic Ocular Graft-Versus-Host Disease (oGHVD)

Inclusion Criteria:

• Age ≥ 18 years.
• Willing and able to provide written informed consent.
• Willing and able to comply with study assessments for the full duration of the study.
• Patients may be using bilateral scleral lenses and/or bilateral punctal plugs at the time of accrual.
• Minimum Oxford Schema grad of ≥ 1 in at least one eye.
• OSDI scored of ≥ 22.
• UNC DEMS score of ≥ 3.
• In good stable overall health.

Exclusion Criteria:

• History of Rheumatoid Arthritis, Lupus, Scleroderma.
• Ocular or periocular malignancy.
• Significant change, as judged by the principal investigator, in systemic immunosuppressive regimen within 2 weeks of study entry.
• Any history of topical tacrolimus use.
• Any change in dosage of tetracycline compounds (tetracycline, doxycycline, and minocycline) within the last month.
• Any change in frequency of preserved anti-glaucoma medications within 2 weeks of study entry.
• Current use of topical steroids more than twice a day.
• Corneal epithelial defect > 1mm2.
• Any history of herpetic keratitis.
• Participation in another simultaneous medical research study.
• Signs of current infection, including fever and current treatment with antibiotics.
• All vaccination including COVID are prohibited during this study.
• Signs of current infection, including fever and current treatment with antibiotics.
• All vaccinations including COVID are prohibited during this study.
• Intra-ocular surgery or ocular laser surgery within 3 months.
• Women who are pregnant, breastfeeding, or plan to become pregnant while participating in the study. If of childbearing potential, unwillingness to use effective birth control while participating in the study.
• Any condition (including language barrier) that precludes patient's ability to comply with study requirements including completion of study.