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

University Hospital Freiburg

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Penetrating Keratoplasty

Treatments: Drug: FK506 0.06% (eye drops)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00463723

FR-2000-2003

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind