Back to resultsLoteprednol Etabonate 0.25% for Prevention of Cornea Transplant Rejection
Primary Purpose
Corneal Endothelial Dystrophy, Corneal Edema
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
loteprednol etabonate 0.25% ophthalmic suspension
Sponsored by
About this trial
This is an interventional prevention trial for Corneal Endothelial Dystrophy
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
Sites / Locations
- Price Vision Group
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Preventative Treatment
Arm Description
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.
Outcomes
Primary Outcome Measures
Immunologic rejection
incidence of immunologic rejection episodes
steroid-induced ocular hypertension
incidence of steroid-induced ocular hypertension
Secondary Outcome Measures
Full Information
NCT ID
NCT05136443
First Posted
October 29, 2021
Last Updated
September 5, 2023
Sponsor
Price Vision Group
Collaborators
Kala Pharmaceuticals, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT05136443
Brief Title
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
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
November 23, 2021 (Actual)
Primary Completion Date
September 5, 2023 (Actual)
Study Completion Date
September 5, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Price Vision Group
Collaborators
Kala Pharmaceuticals, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Corneal Endothelial Dystrophy, Corneal Edema
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
71 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Preventative Treatment
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
loteprednol etabonate 0.25% ophthalmic suspension
Other Intervention Name(s)
Eysuvis
Intervention Description
tapering dose
Primary Outcome Measure Information:
Title
Immunologic rejection
Description
incidence of immunologic rejection episodes
Time Frame
11 months
Title
steroid-induced ocular hypertension
Description
incidence of steroid-induced ocular hypertension
Time Frame
11 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francis W Price, Jr., MD
Organizational Affiliation
Price Vision Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
Price Vision Group
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
26020827
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.
Results Reference
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PubMed Identifier
25062336
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.
Results Reference
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Loteprednol Etabonate 0.25% for Prevention of Cornea Transplant Rejection
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