N/A
Completed N=75
Treatment of Ocular Graft-versus-Host Disease (GVHD) With Topical Loteprednol Etabonate 0.5%
Dry Eyes
Source: ClinicalTrials.gov NCT01695668 ↗
Enrolled (actual)
75
Serious AEs
34.7%
Results posted
Sep 2015
Primary outcomePrimary: Progression of Dry Eye Severity — 15; 12 patients with increased dry eye severity
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression of Dry Eye Severity |
15; 12 | — |
Eligibility Criteria
Inclusion Criteria
Scheduled for allogenic bone marrow transplant
Exclusion Criteria
Allergic reaction to loteprednol or cyclosporine, previous allogenic transplant
Data sourced from ClinicalTrials.gov (NCT01695668). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.