Loteprednol Etabonate 0.25% for Prevention of Cornea Transplant Rejection

NCT05136443 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: 2021-002
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Corneal Endothelial Dystrophy; Corneal Edema

Outcome Measures

Primary Outcomes (2)

• Immunologic Rejection

  incidence of immunologic rejection episodes

  11 months

• Steroid-induced Ocular Hypertension

  incidence of steroid-induced ocular hypertension

  11 months

Study Arms (1)

Preventative Treatment

EXPERIMENTAL

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

Interventions

loteprednol etabonate 0.25% ophthalmic suspension DRUG

tapering dose

Also known as: Eysuvis

Preventative Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Price Vision Group: lead
• Kala Pharmaceuticals, Inc.: collaborator

Study Sites (1)

Price Vision Group

Indianapolis, Indiana, 46260, United States

Location

Related Publications (3)

• 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.

  PMID: 26020827 BACKGROUND

• 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.

  PMID: 25062336 BACKGROUND

• 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.

  PMID: 37733966 RESULT

MeSH Terms

Conditions

Corneal Dystrophy, Posterior Polymorphous, 1; Corneal Edema

Interventions

Loteprednol Etabonate

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Marianne Price
• Organization: Cornea Research Foundation of America

mprice@cornea.org

317-814-2990

Study Officials

• Francis W Price, Jr., MD

  Price Vision Group

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2021
• First Posted: November 29, 2021
• Study Start: November 23, 2021
• Primary Completion: September 5, 2023
• Study Completion: September 5, 2023
• Last Updated: August 14, 2024
• Results First Posted: August 14, 2024

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)