Safety and Efficacy Study of R932348 Ophthalmic Solution in Chronic Ocular Graft Versus Host Disease Patients(DROPS-2)

Phase 2, Multi-Center, Randomized, Double-Masked, Placebo-Controlled Clinical Study to Assess the Safety and Efficacy of 0.2% and 0.5% R932348 Ophthalmic Solutions for the Treatment of Keratoconjunctivitis Sicca in Patients With Chronic Ocular Graft Versus Host Disease

• To assess the efficacy of R348 Ophthalmic Solutions administered for 12 weeks to subjects evaluated by objective and subjective measures.
• To investigate the safety and tolerability of R348 Ophthalmic Solutions administered for 12 weeks to subjects.

Inclusion Criteria:

• Received an Allogeneic hematologic stem cell transplantation at least 3 months prior.
• Subjects with post Allogeneic hematologic stem cell transplantation onset or worsening of dry eye symptoms for at least 1 month prior.
• Use of over-the-counter and/or prescription eye drops for dry eye symptoms within 1 month.
• Corneal fluorescein staining score of ≥ 2 in 1 region and ≥ 1 in at least 1 other region.
• Total lissamine green conjunctival staining score (according to a modified National Eye Institute grading system) of ≥ 2.

Exclusion Criteria:

• Clinically unstable Graft versus Host Disease (requiring a change in immunosuppressive regimen), medical condition, or laboratory abnormality
• Used topical ophthalmic cyclosporine within 45 days.
• Used any topical ophthalmic steroid within 2 weeks.
• Used autologous serum eye drops within 2 weeks.