Overview
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)
Eligibility
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.