N/A N=75 Randomized Prevention

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

Dry Eyes

Bottom Line

View on ClinicalTrials.gov: NCT01695668 ↗

Enrolled (actual)

Serious AEs

34.7%

Results posted

Sep 2015

Primary outcome: Primary: Progression of Dry Eye Severity — 15; 12 patients with increased dry eye severity

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Lotemax (Drug); Restasis (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Michigan
Primary completion: Sep 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Progression of Dry Eye Severity	15; 12	—

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.

Eligibility Criteria

Inclusion Criteria

Scheduled for allogenic bone marrow transplant

Exclusion Criteria

Allergic reaction to loteprednol or cyclosporine, previous allogenic transplant

View full record on ClinicalTrials.gov →

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.