drugset / Trial / NCT01695668

Treatment of Ocular Graft-versus-Host Disease (GVHD) With Topical Loteprednol Etabonate 0.5%

NCT01695668

RandomizedParallel-groupOpen-labelPrevention

Summary

The purpose of this research is to: 1. Evaluate the safety and efficacy of a steroid eye drop (Lotemax) in patients who have been diagnosed with graft-versus-host disease (GVHD), which is a complication that may occur after bone marrow transplant where the newly transplanted material attacks the patient's body and may cause eye dryness. 2. Assess the safety and efficacy of Lotemax in decreasing the eye's reaction to the process in GVHD before the patient undergoes bone marrow transplant. 3. Compare how well Lotemax works in decreasing the process in GVHD with an immunosuppressive eye drop (Restasis), which has been commonly used in the treatment of this condition.

Timeline

Start
2011-08
Primary completion
2013-09
Completion
2015-02

Drugs

EvaluationDrugModalityDoseRoute
Comparator Cyclosporine Peptide 0.05 % Topical
Subject Loteprednol Etabonate Other / unclassified 0.5 % Topical

Indications