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NCT Number: NCT05136443

Loteprednol Etabonate 0.25% for Prevention of Cornea Transplant Rejection

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.

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Key information

Conditions

Corneal Endothelial Dystrophy Corneal Diseases Corneal Dystrophy, Posterior Polymorphous, 1 Corneal Edema Eye Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Price Vision Group

Indianapolis, Indiana, 46260, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

loteprednol etabonate 0.25% ophthalmic suspension

Drug

tapering dose

Other names: Eysuvis

Primary outcomes

  1. Immunologic Rejection

    Time frame: 11 months

    incidence of immunologic rejection episodes

  2. Steroid-induced Ocular Hypertension

    Time frame: 11 months

    incidence of steroid-induced ocular hypertension

Sponsors and collaborators

Lead sponsor

Price Vision Group

Industry

Collaborators

  • Kala Pharmaceuticals, Inc.

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Nov 29, 2021
Registry last updated
Aug 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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