Clareo Health | Study of d-MAPPS™ Ophthalmic Solution, Safety, Tolerability, and Efficacy in the Treatment of Chronic Ocular Graft-Versus-Host Disease (oGVHD)
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Regenerative Ocular Immunobiologics LLC
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
