Loteprednol Etabonate 0.25% for Prevention of Cornea Transplant Rejection

Phase 4

Completed

• Conditions: Corneal Endothelial Dystrophy; Corneal Edema
• Interventions: Drug: loteprednol etabonate 0.25% ophthalmic suspension

• Registration Number: NCT05136443
• Lead Sponsor: Price Vision Group

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-10-29
• Study First Submitted QC: 2021-11-17
• Study Start: 2021-11-23
• Study First Posted: 2021-11-29
• Status Verified: 2023-09
• Primary Completion: 2023-09-05
• Study Completion: 2023-09-05
• Results First Submitted: 2024-07-23
• Results First Submitted QC: 2024-07-23
• Last Update Submitted: 2024-07-23
• Results First Posted: 2024-08-14
• Last Update Posted: 2024-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Preventative Treatment	loteprednol etabonate 0.25% ophthalmic suspension	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.

Primary Outcome Measures

Name	Time	Method
Immunologic Rejection	11 months	incidence of immunologic rejection episodes
Steroid-induced Ocular Hypertension	11 months	incidence of steroid-induced ocular hypertension

Trial Locations

Locations (1)

Price Vision Group; 🇺🇸 Indianapolis, Indiana, United States