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Topical FK506 (Tacrolimus) for Prevention of Immune Reactions Following Penetrating Keratoplasty

NCT00463723 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL

Last updated 2007-04-20

No results posted yet for this study

Summary

Background: Patients following allogeneic keratoplasty are treated with topical and frequently with systemic steroids to prevent immune reactions. Steroids are known to yield good results, but exert a wide range of side effects. The efficacy of topial FK506 in preventing immune reactions has already been demonstrated experimentally. FK506, an IL-2-inhibitor like Cyclosporin A (CSA), is known to be approximately 100 fold more potent than CSA. Aim of the study: In this study the efficacy and safety of topical FK506 will be compared to our standard treatment (i.e. steroids) after penetrating normal-risk keratoplasty.

Conditions

  • Penetrating Keratoplasty

Interventions

DRUG

FK506 0.06% (eye drops)

Sponsors & Collaborators

  • Sucampo Pharmaceuticals, Inc.

    collaborator INDUSTRY

  • University Hospital Freiburg

    lead OTHER

Principal Investigators

  • Thomas Reinhard, MD · University eye hospital Freiburg, Germany

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00463723 on ClinicalTrials.gov