Loteprednol Etabonate 0.25% for Prevention of Cornea Transplant Rejection

Corneal Edema Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05136443
• Other study ID #: 2021-002
• Status: Completed
• Phase: Phase 4
• Start date: November 23, 2021
• Est. completion date: September 5, 2023

Study information

• Verified date: September 2023
• Source: Price Vision Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: September 5, 2023
• Est. primary completion date: September 5, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Corneal Edema
• Corneal Endothelial Dystrophy

Intervention

Drug:
• loteprednol etabonate 0.25% ophthalmic suspension
tapering dose

Locations

Country	Name	City	State
United States	Price Vision Group	Indianapolis	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Price Vision Group	Kala Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immunologic rejection	incidence of immunologic rejection episodes	11 months
Primary	steroid-induced ocular hypertension	incidence of steroid-induced ocular hypertension	11 months