Loteprednol Etabonate 0.25% for Prevention of Cornea Transplant Rejection
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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|
Phase 4 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Preventative Treatment 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
tapering dose
Other Names:
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Outcome Measures
Primary Outcome Measures
- Immunologic rejection [11 months]
incidence of immunologic rejection episodes
- steroid-induced ocular hypertension [11 months]
incidence of steroid-induced ocular hypertension
Eligibility Criteria
Criteria
Inclusion Criteria:
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o At least 18 years of age
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Male or female patient who had DMEK within the past 1 to 7 weeks.
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Patient is able and willing to administer eye drops.
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Patient is able to comprehend and has signed the Informed Consent form.
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Patient is likely to complete the 11-month study duration.
Exclusion Criteria:
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o A history of a previous rejection episode in the study eye
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A patient exhibiting intraocular inflammation.
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A patient with a known sensitivity to any of the ingredients in the study medications
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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
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A patient with abnormal eyelid function.
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A patient that is exhibiting active corneal ulceration, keratitis, or conjunctivitis, or who has a history of herpetic keratitis.
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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.
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A patient with a history of non-compliance with using prescribed medication.
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Patients who are pregnant or planning to become pregnant within the duration of the study
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Price Vision Group | Indianapolis | Indiana | United States | 46260 |
Sponsors and Collaborators
- Price Vision Group
- Kala Pharmaceuticals, Inc.
Investigators
- Principal Investigator: Francis W Price, Jr., MD, Price Vision Group
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 2021-002