Loteprednol Etabonate 0.25% for Prevention of Cornea Transplant Rejection

Price Vision Group (Industry)
Overall Status
CT.gov ID
Kala Pharmaceuticals, Inc. (Industry)

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: loteprednol etabonate 0.25% ophthalmic suspension
Phase 4

Study Design

Study Type:
Anticipated Enrollment :
116 participants
Intervention Model:
Single Group Assignment
None (Open Label)
Primary Purpose:
Official Title:
Prospective Analysis of Loteprednol Etabonate Ophthalmic Suspension 0.25% for Prevention of Immunologic Rejection After Descemet Membrane Endothelial Keratoplasty
Actual Study Start Date :
Nov 23, 2021
Anticipated Primary Completion Date :
Jan 1, 2023
Anticipated Study Completion Date :
Feb 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Preventative Treatment

Loteprednol etabonate ophthalmic suspension 0.25% dosed 4 times daily for 2 months, 3 times daily for one month, twice daily for one month, and once daily until the 1 year postop exam.

Drug: loteprednol etabonate 0.25% ophthalmic suspension
tapering dose
Other Names:
  • Eysuvis
  • Outcome Measures

    Primary Outcome Measures

    1. Immunologic rejection [11 months]

      incidence of immunologic rejection episodes

    2. steroid-induced ocular hypertension [11 months]

      incidence of steroid-induced ocular hypertension

    Eligibility Criteria


    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Accepts Healthy Volunteers:
    Inclusion Criteria:
    • o At least 18 years of age

    • Male or female patient who had DMEK within the past 1 to 7 weeks.

    • Patient is able and willing to administer eye drops.

    • Patient is able to comprehend and has signed the Informed Consent form.

    • Patient is likely to complete the 11-month study duration.

    Exclusion Criteria:
    • o A history of a previous rejection episode in the study eye

    • A patient exhibiting intraocular inflammation.

    • A patient with a known sensitivity to any of the ingredients in the study medications

    • A patient who has a condition (i.e., UNCONTROLLED systemic disease) or is in a situation which in the investigator's opinion may put the patient at significant risk, may confound the study results, or may interfere significantly with the patient's participation in the study

    • A patient with abnormal eyelid function.

    • A patient that is exhibiting active corneal ulceration, keratitis, or conjunctivitis, or who has a history of herpetic keratitis.

    • Presence of any ocular disease that would interfere with the evaluation of the study treatment. However, patients with a history of cystoid macular edema, age-related macular degeneration, controlled glaucoma, corneal neovascularization, and other non-interfering comorbidities may be enrolled.

    • A patient with a history of non-compliance with using prescribed medication.

    • Patients who are pregnant or planning to become pregnant within the duration of the study

    Contacts and Locations


    Site City State Country Postal Code
    1 Price Vision Group Indianapolis Indiana United States 46260

    Sponsors and Collaborators

    • Price Vision Group
    • Kala Pharmaceuticals, Inc.


    • Principal Investigator: Francis W Price, Jr., MD, Price Vision Group

    Study Documents (Full-Text)

    None provided.

    More Information


    Responsible Party:
    Price Vision Group
    ClinicalTrials.gov Identifier:
    Other Study ID Numbers:
    • 2021-002
    First Posted:
    Nov 29, 2021
    Last Update Posted:
    Dec 13, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Plan to Share IPD:
    Studies a U.S. FDA-regulated Drug Product:
    Studies a U.S. FDA-regulated Device Product:
    Product Manufactured in and Exported from the U.S.:
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 13, 2021