This Phase 2/3 placebo-controlled clinical study of Safety and Efficacy of Pro-ocular™ 1% in Daily Scleral Lens Wearing Patients with Ocular Graft-versus-Host Disease (oGvHD) will evaluate the the investigational drug's effect on signs and symptoms of oGvHD and subject-reported hours of duration of comfortable and serviceable scleral lens wear time.~The study will enroll 38 subjects. In the first 12 weeks, subjects will be randomized 1:1 active to placebo. At week 12, placebo subjects will cross-over to active drug treatment. At week 24, all subjects can opt into an open label phase.~In clinic visits will occur at weeks 0, 12 and 24 with remote telephone assessments at weeks 6 and 18. For subjects who opt into the open-label phase, in-clinic visits will occur at weeks 36 and 52.~Safety monitoring for adverse events will be performed at all onsite and remote visits.
This clinical study seeks to evaluate the safety and efficacy of Pro-ocular™1% topical gel in patients with ocular Graft-versus-Host Disease who wear scleral lenses daily. This vehicle-controlled trial will evaluate the investigational drug's effect on signs and symptoms of ocular Graft-versus-Host Disease and on the hours of daily comfortable and serviceable scleral lens wear.