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Corticosteroid
Loteprednol Etabonate 0.25% for Prevention of Cornea Transplant Rejection
Phase 4
Waitlist Available
Led By Francis W Price, Jr., MD
Research Sponsored by Price Vision Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 11 months
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial
No Placebo-Only Group
Summary
This trial tests if loteprednol etabonate 0.25% eye drops can prevent rejection in patients with a cornea transplant by reducing inflammation and calming the immune system. Loteprednol etabonate has been used in various concentrations to treat eye inflammation and pain, including after eye surgery and for dry eye disease.
Eligible Conditions
- Fuchs' Dystrophy
- Corneal Edema
- Pseudophakic Corneal Edema
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 11 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~11 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Immunologic Rejection
Steroid-induced Ocular Hypertension
Side effects data
From 2023 Phase 4 trial • 70 Patients • NCT051364433%
Instillation site discomfort
1%
Steroid induced intraocular pressure elevation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Preventative Treatment
Awards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Preventative TreatmentExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
loteprednol etabonate 0.25% ophthalmic suspension
2021
Completed Phase 4
~70
Find a Location
Who is running the clinical trial?
Kala Pharmaceuticals, Inc.Industry Sponsor
10 Previous Clinical Trials
4,092 Total Patients Enrolled
Price Vision GroupLead Sponsor
11 Previous Clinical Trials
1,612 Total Patients Enrolled
3 Trials studying Corneal Edema
169 Patients Enrolled for Corneal Edema
Francis W Price, Jr., MDPrincipal InvestigatorPrice Vision Group
5 Previous Clinical Trials
3,377 Total Patients Enrolled
1 Trials studying Corneal Edema
167 Patients Enrolled for Corneal Edema