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

Status
Terminated
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00463723
Enrollment
Unknown
Registered
2007-04-20
Start date
Unknown
Completion date
Unknown
Last updated
2007-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Penetrating Keratoplasty

Keywords

penetrating keratoplasty, graft rejection, immunosuppression

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.

Interventions

DRUGFK506 0.06% (eye drops)

Sponsors

Sucampo Pharmaceuticals, Inc.
CollaboratorINDUSTRY
University Hospital Freiburg
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026