Phase
Condition
N/ATreatment
d-Mapps
Placebo
PI and Patient Masked
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 thestudy.
Patients may be using bilateral scleral lenses and/or bilateral punctal plugs at thetime 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
Exclusion Criteria:
History of Rheumatoid Arthritis, Lupus, Scleroderma.
Ocular or periocular malignancy.
Significant change, as judged by the principal investigator, in systemicimmunosuppressive regimen within 2 weeks of study entry.
Any history of topical tacrolimus use.
Any change in dosage of tetracycline compounds (tetracycline, doxycycline, andminocycline) within the last month.
Any change in frequency of preserved anti-glaucoma medications within 2 weeks ofstudy 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 whileparticipating in the study. If of childbearing potential, unwillingness to useeffective birth control while participating in the study.
Any condition (including language barrier) that precludes patient's ability tocomply with study requirements including completion of study.
Study Design
Connect with a study center
Beach Eye Medical Group
Huntington Beach, California 92648
United StatesActive - Recruiting
Regenerative Ocular Immunobiologics, LLC.
Palm Harbor, Florida 34684
United StatesActive - Recruiting
Kentucky Eye Institute
Lexington, Kentucky 40517
United StatesActive - Recruiting
Eyewell, LLC.
Boston, Massachusetts 02215
United StatesActive - Recruiting
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