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

Completed · Phase 2 · Has a placebo group

Conditions studied: Chronic Graft-versus-host Disease

In brief

* 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.

Key facts

Study ID

NCT02040623

Run by

Rigel Pharmaceuticals

People needed

35

Starts

2014-03-01

Expected to finish

2016-07-01

Last updated by the study team

2016-10-10

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• U. Miami - Bascom Palmer Eye Institute — Plantation, Florida, United States
• Massachusetts Eye and Ear Infirmary — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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