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

Status:	Completed
Conditions:	Ocular, Hematology
Therapuetic Areas:	Hematology, Ophthalmology
Healthy:	No
Age Range:	18 - 85
Updated:	7/14/2016
Start Date:	March 2014
End Date:	July 2016

A 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.

We found this trial at

sites

U. Miami - Bascom Palmer Eye Institute

Plantation, Florida 33324

Principal Investigator: Victor Perez, MD

Phone: 305-326-6302

from

Plantation, FL