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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

Study Summary

This trial is testing whether loteprednol etabonate 0.25% ophthalmic suspension (Eysuvis) is effective in preventing immunologic rejection in the first year after Descemet membrane endothelial keratoplasty (DMEK).

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Immunologic rejection
steroid-induced ocular hypertension

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
~80

Find a Location

Who is running the clinical trial?

Kala Pharmaceuticals, Inc.Industry Sponsor
10 Previous Clinical Trials
4,004 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this experiment still seeking participants to enroll?

"Affirmative. According to the clinicaltrials.gov website, this scientific trial is actively recruiting participants and opened on November 23rd 2021. As of now, 116 patients are being recruited at just one medical facility with its last update occurring on the 29th of November 2021."

Answered by AI

How many patients are participating in this clinical trial?

"Affirmative. Clinicaltrials.gov contains data which demonstrates that this research endeavour is actively searching for participants, with the initial posting on November 23rd 2021 and a recent update on November 29th 2021. In total 118 individuals are needed from a single location."

Answered by AI

Has a similar research project been conducted prior to this one?

"The research surrounding loteprednol etabonate 0.25% ophthalmic suspension began in 2021, when Price Vision Group funded the first trial of 116 participants. After passing through four stages of drug approval, it is now only subject to one active study sponsored by Price Vision Group."

Answered by AI

What maladies can be effectively alleviated with loteprednol etabonate 0.25% ophthalmic suspension?

"Loteprednol etabonate 0.25% ophthalmic suspension can be utilized to effectively address dry eye syndrome, associated discomfort, and other eye issues."

Answered by AI

Has loteprednol etabonate 0.25% ophthalmic suspension been assessed in prior experiments?

"Currently, there is one ongoing investigation into the efficacy of loteprednol etabonate 0.25% ophthalmic suspension with no studies in Phase 3. While Indianapolis houses multiple trials for this medication, at least one other site is recruiting patients to take part."

Answered by AI

Has the FDA authorized loteprednol etabonate 0.25% ophthalmic suspension?

"Taking into account the fact that this is a Phase 4 medical trial, which implies that loteprednol etabonate 0.25% ophthalmic suspension has already been approved for use; our team at Power rated it with 3 out of 3 on safety scale."

Answered by AI
~21 spots leftby Apr 2025