NCT05136443

Loteprednol Etabonate 0.25% for Prevention of Cornea Transplant Rejection

Prospective Analysis of Loteprednol Etabonate Ophthalmic Suspension 0.25% for Prevention of Immunologic Rejection After Descemet Membrane Endothelial Keratoplasty

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Price Vision Group · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess off-label use of loteprednol etabonate 0.25% ophthalmic suspension (Eysuvis) for prevention of immunologic rejection in the first year after Descemet membrane endothelial keratoplasty (DMEK). Topical corticosteroids have long been the mainstay for preventing and treating cornea transplant rejection although none are specifically approved for this purpose. The rates of immunologic rejection episodes and steroid-induced ocular hypertension will be compared with the respective rates observed in earlier studies with prednisolone acetate 1% suspension, loteprednol etabonate 0.5% gel, and fluorometholone 0.1% suspension after DMEK.

Conditions

• Corneal Endothelial Dystrophy
• Corneal Edema

Interventions

Type	Name	Description
DRUG	loteprednol etabonate 0.25% ophthalmic suspension	tapering dose

Timeline

• Start date: 2021-11-23
• Primary completion: 2023-09-05
• Completion: 2023-09-05
• First posted: 2021-11-29
• Last updated: 2024-08-14
• Results posted: 2024-08-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study