CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 70 enrolled
Drug / intervention
loteprednol etabonate 0.25% ophthalmic suspensiondrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05136443
NCT05136443Phase 4Completed

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

Price Vision Group·interventional·Posted Nov 29, 2021·Updated Aug 14, 2024

In Brief

A Phase 4 clinical trial evaluating loteprednol etabonate 0.25% ophthalmic suspension for Corneal Endothelial Dystrophy and Corneal Edema. Completed, enrolled 70 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 4CompletedFinished
20222023202420252026
First PostedNov 29, 2021
Enrollment StartNov 23, 2021
Primary CompletionSep 5, 2023
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 4.6 years ago

Interventions

loteprednol etabonate 0.25% ophthalmic suspensiondrug

tapering dose