Clinical trial NCT05136443: Loteprednol Etabonate 0.25% for Prevention of Cornea Transplant Rejection
Official title: Prospective Analysis of Loteprednol Etabonate Ophthalmic Suspension 0.25% for Prevention of Immunologic Rejection After Descemet Membrane Endothelial Keratoplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Corneal Endothelial Dystrophy
Corneal Edema
Lead sponsor: Price Vision Group
Sponsor class: INDUSTRY
Collaborators: name: Kala Pharmaceuticals, Inc.
First posted: 2021-11-29
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Immunologic Rejection
timeFrame: 11 months
measure: Steroid-induced Ocular Hypertension
timeFrame: 11 months
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Price Vision Group
state: Indiana
Study officials:
affiliation: Price Vision Group
name: Francis W Price, Jr., MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Price MO, Feng MT, Scanameo A, Price FW Jr. Loteprednol Etabonate 0.5% Gel Vs. Prednisolone Acetate 1% Solution After Descemet Membrane Endothelial Keratoplasty: Prospective Randomized Trial. Cornea. 2015 Aug;34(8):853-8. doi: 10.1097/ICO.0000000000000475.
citation: Price MO, Price FW Jr, Kruse FE, Bachmann BO, Tourtas T. Randomized comparison of topical prednisolone acetate 1% versus fluorometholone 0.1% in the first year after descemet membrane endothelial keratoplasty. Cornea. 2014 Sep;33(9):880-6. doi: 10.1097/ICO.0000000000000206.
citation: Price MO, Feng MT, Gang A, Price FW Jr. Prospective Assessment of Loteprednol Etabonate 0.25% for Prevention of Immunologic Rejection After Descemet Membrane Endothelial Keratoplasty in Eyes With Fuchs Dystrophy. Cornea. 2024 Aug 1;43(8):1028-1030. doi: 10.1097/ICO.0000000000003398. Epub 2023 Sep 21.