Safety and Efficacy of Pro-ocular™ 1% in Daily Scleral Lens Wearing Patients With Ocular Graft-versus-Host Disease

Exclusion Criteria

• •1. Has tested positive from COVID-19 within twenty-eight days prior to Screening.
• •2. Active trigeminal neuritis, trigeminal neuralgia, ocular herpes zoster, facial herpes zoster, ocular herpes simplex, or neurotrophic keratitis at Visit 1.
• •3. History of ocular herpes zoster, facial herpes zoster, ocular herpes simplex, or neurotrophic keratitis within the last 5 years that is not being medically managed including oral antivirals. Patients with a history of herpes simplex virus must be receiving appropriate antiviral therapy.
• •4. History of breast cancer in patient or immediate biological family (parents, siblings and children).
• •5. Eyelid surgery or ocular surgery within the last 12 weeks prior to screening that in the judgment of the clinical investigator will interfere with study assessments.
• •6. Comorbidity with other severe, acute or chronic systemic or ocular condition that in the judgment of the investigator will interfere with study assessments, study participant safety, or study compliance such as active COVID-19 infection.
• •7. Significant change (e.g. discontinuation) in oral corticosteroid dose or corticosteroid-containing eye drops or gels, cyclosporine ophthalmic emulsion or lifitegrast ophthalmic solution within 7 days prior to screening.
• •8. Wears any type of lenses overnight (e.g. scleral lenses, bandage contact lenses).
• •9. Women of childbearing potential who are pregnant, nursing an infant, planning a pregnancy, not receiving an adequate method of birth control, or have a positive urine pregnancy test at Screening. Women of childbearing potential must be willing to use contraception throughout this study.
• •10. Has a known adverse reaction and/or sensitivity to the study drug.
• •11. Prior or current use of Pro-ocular™.
• •12. Unwilling to cease the use of sunscreen on the forehead or eye area.
• •13. Currently using more than one preserved topical medication for glaucoma.
• •14. Currently enrolled in an investigational drug or device study exclusively for ocular GvHD.