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Loteprednol Etabonate 0.25% for Prevention of Cornea Transplant Rejection

NCT05136443 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2024-08-14

Study results available
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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

DRUG

loteprednol etabonate 0.25% ophthalmic suspension

tapering dose

Sponsors & Collaborators

  • Kala Pharmaceuticals, Inc.

    collaborator INDUSTRY

  • Price Vision Group

    lead INDUSTRY

Principal Investigators

  • Francis W Price, Jr., MD · Price Vision Group

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-23
Primary Completion
2023-09-05
Completion
2023-09-05
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05136443 on ClinicalTrials.gov