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Corticosteroid

Steroids and Cross-linking for Corneal Ulcers (SCUT II Trial)

Phase 3

Waitlist Available

Led By Tom Lietman, MD

Research Sponsored by Thomas M. Lietman

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Moderate to severe vision loss, defined as Snellen visual acuity of 20/40 (6/12) or worse

Age over 18 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 weeks, 3 months, 6 months 12 months

Awards & highlights

SCUT II Trial Summary

This trial is being done to compare the effectiveness of two treatments for corneal ulcers, one that uses just antibiotics and one that uses a combination of antibiotics and a procedure called collagen cross-linking.

Who is the study for?

This trial is for adults over 18 with bacterial corneal ulcers and vision loss of 20/40 or worse. They must have a certain corneal thickness, understand the study, and commit to follow-up visits. It's not for those with non-infectious keratitis, recent eye surgery, very poor vision in the other eye, cognitive impairments, multiple infections or imminent corneal perforation.Check my eligibility

What is being tested?

SCUT II compares three treatments: standard therapy (antibiotic plus placebo), early steroids (antibiotic plus steroid), and cross-linking with early steroids (CXL). Patients are randomly assigned to one group and double-masked means neither they nor the doctors know which treatment they receive.See study design

What are the potential side effects?

Possible side effects include irritation from topical treatments like burning or stinging sensations in the eyes. Steroids may increase pressure inside the eye or cause cataracts over long-term use. CXL might lead to temporary haziness of vision.

SCUT II Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My vision is 20/40 or worse.

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I am over 18 years old.

SCUT II Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 weeks, 3 months, 6 months 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 weeks, 3 months, 6 months 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 weeks, 3 months, 6 months 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Secondary outcome measures

Adverse Events

Best Spectacle-Corrected Visual Acuity

Number of Ulcers Testing Positive for Bacteria on Repeat Culture

+2 more

SCUT II Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Early SteroidsExperimental Treatment2 Interventions

Participants in this arm will receive topical 0.5% moxifloxacin plus topical steroids plus sham corneal cross-linking.

Group II: Cross-Linking plus Early SteroidsExperimental Treatment3 Interventions

Participants in this group will receive topical 0.5% moxifloxacin plus topical steroids plus corneal cross-linking.

Group III: Standard TherapyPlacebo Group3 Interventions

Participants in this arm will receive topical 0.5% moxifloxacin plus topical placebo plus sham corneal cross-linking.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Moxifloxacin Ophthalmic

2011

Completed Phase 4

~180

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Eye Institute (NEI)NIH

546 Previous Clinical Trials

1,401,649 Total Patients Enrolled

Thomas M. LietmanLead Sponsor

3 Previous Clinical Trials

1,093 Total Patients Enrolled

Stanford UniversityOTHER

2,387 Previous Clinical Trials

17,333,771 Total Patients Enrolled

1 Trials studying Bacterial Keratitis

60 Patients Enrolled for Bacterial Keratitis

Media Library

Difluprednate Ophthalmic (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT04097730 — Phase 3

Bacterial Keratitis Research Study Groups: Standard Therapy, Cross-Linking plus Early Steroids, Early Steroids

Bacterial Keratitis Clinical Trial 2023: Difluprednate Ophthalmic Highlights & Side Effects. Trial Name: NCT04097730 — Phase 3

Difluprednate Ophthalmic (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04097730 — Phase 3

Frequently Asked Questions

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

Are there other examples of Difluprednate Ophthalmic being used in medical research?

"Difluprednate Ophthalmic was first investigated in 2010 at the Cornea and Laser Eye Institute. Since then, 406 clinical trials have completed with 46 ongoing studies. The majority of these live trials are based in San Francisco and Florida."

Answered by AI

For what purpose is Difluprednate Ophthalmic most commonly prescribed?

"Difluprednate Ophthalmic can be used to help people with bacterial conjunctivitis, as well as those who need dietary or nutritional therapies, and those suffering from vitamin deficiency."

Answered by AI

Has Difluprednate Ophthalmic undergone FDA approval?

"Difluprednate Ophthalmic received a score of 3 for safety. This is because Phase 3 trials have some data showing the medication is effective and multiple rounds of data demonstrating that the drug is safe."

Answered by AI