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Corticosteroid

loteprednol etabonate 0.25% ophthalmic suspension for Corneal Edema

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
Pivotal Trial
Drug Has Already Been Approved
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
  • Corneal Edema
  • Fuchs' Dystrophy

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~11 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 11 months for reporting.

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 • NCT05136443
3%
Instillation site discomfort
1%
Steroid induced intraocular pressure elevation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Preventative Treatment

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
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
~18 spots leftby Nov 2025
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