CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 75 enrolled
Drug / intervention
Lotemax +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01695668
NCT01695668N/ACompleted
CompareCT.gov

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

University of Michigan·interventional·Posted Sep 28, 2012·Updated Sep 24, 2015

In Brief

A clinical study evaluating Lotemax and Restasis for Dry Eyes. Completed, enrolled 75 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDry Eyes
Countries--
CollaboratorsBausch & Lomb Incorporated

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedSep 28, 2012
Enrollment StartAug 1, 2011
Primary CompletionSep 1, 2013
Study CompletionFeb 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 13.8 years ago

Interventions

Lotemaxdrug

Ophthalmic corticosteroid. It decreases inflammation of the eye

Restasisdrug

Restasis is an immunosuppressive agent. Cyclosporine may reduce inflammation in the eye.