CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 164 enrolled
Drug / intervention
cyclosporine ophthalmic emulsion +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/NCT00755040
NCT00755040Phase 3Completed
CompareCT.gov

Randomized Placebo Controlled Double Blind Study of Restasis Versus Placebo in Primary Prevention of Ocular GVHD After Allogeneic Stem Cell Transplantation

Vanderbilt-Ingram Cancer Center·interventional·Posted Sep 18, 2008·Updated Mar 7, 2017

In Brief

A Phase 3 clinical trial evaluating cyclosporine ophthalmic emulsion and placebo for Chronic Myeloproliferative Disorders and 6 related conditions. Completed, enrolled 164 participants across 5 sites.

Detailed Summary

RATIONALE: Cyclosporine eye drops may prevent graft-versus-host disease of the eye in patients who have undergone donor stem cell transplant for hematologic cancer or bone marrow failure disorder. PURPOSE: This randomized phase I trial is studying how well cyclosporine eye drops work in preventing graft-versus-host disease of the eye in patients who have undergone donor stem cell transplant for hematologic cancer or bone marrow failure disorder.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Myeloproliferative Disorders, Graft Versus Host Disease, Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Neoplasms
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 18, 2008
Enrollment StartOct 1, 2008
Primary CompletionDec 1, 2014
Study CompletionMay 1, 2016
TodayJul 2, 2026
Enrollment to primary: 6.2 yearsPosted 17.8 years ago

Interventions

cyclosporine ophthalmic emulsiondrug

Given as eye drops

placeboother

Given as eye drops