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

• Status: Completed
• Trial end date: 2016-07-01
• Target enrollment: 0
• Participant gender: All

Summary

• 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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rigel Pharmaceuticals
• Treatments: Ophthalmic Solutions; Pharmaceutical Solutions

Criteria

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.