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

Sponsor
University Hospital Freiburg (Other)
Overall Status
Terminated
CT.gov ID
NCT00463723
Collaborator
Sucampo Pharmaceuticals, Inc. (Industry)

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: FK506 0.06% (eye drops)
 Phase 2/Phase 3

Study Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single
Primary Purpose:
Prevention

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Penetrating keratoplasty for Keratoconus

    • Penetrating keratoplasty for Fuchs endothelial dystrophie

    • Penetrating keratoplasty for Bullous keratopathy

    Exclusion Criteria:

    • Glaucoma

    • Limbal stem cell deficiency

    • Herpetic eye disease

    • Repeat Keratoplasty

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • University Hospital Freiburg
    • Sucampo Pharmaceuticals, Inc.

    Investigators

    • Study Chair: Thomas Reinhard, MD, University eye hospital Freiburg, Germany

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00463723
    Other Study ID Numbers:
    • FR-2000-2003
    First Posted:
    Apr 20, 2007
    Last Update Posted:
    Apr 20, 2007
    Last Verified:
    Aug 1, 1999
    Keywords provided by , ,
    penetrating keratoplasty
    graft rejection
    immunosuppression
    Additional relevant MeSH terms:
    Ophthalmic Solutions

    Study Results

    No Results Posted as of Apr 20, 2007