Steroids and Cross-linking for Ulcer Treatment

Keratitis Bacterial Clinical Trial

— SCUT II  

Official title:

Steroids and Cross-linking for Ulcer Treatment

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04097730
• Other study ID #: 18-26045
• Secondary ID: UG1EY028518
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: September 24, 2020
• Est. completion date: November 30, 2024

Study information

• Verified date: May 2024
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Steroids and Cross-linking for Ulcer Treatment (SCUT II) is an international, randomized, double-masked, clinical trial. The purpose of this study is to determine differences in 6-month visual acuity between medical antimicrobial treatments alone versus antimicrobial treatment plus collagen cross-linking (CXL), as well as to further evaluate findings from subgroup analyses of SCUT. Patients presenting to the Aravind Eye Care System (India), Kaiser Permanente Northern California (USA), or the University of California, San Francisco (USA) with smear-positive and/or culture-positive typical (i.e. non-Nocardia or Mycobacteria) bacterial corneal ulcers and moderate to severe vision loss, defined as Snellen visual acuity of 20/40 or worse, will be eligible for inclusion. Those who agree to participate will be randomized to one of three treatment groups:

Group 1: Standard therapy, topical 0.5% moxifloxacin plus topical placebo plus sham CXL Group 2: Early steroids, topical 0.5% moxifloxacin plus topical difluprednate 0.05% plus sham CXL Group 3: CXL plus early steroids, topical 0.5% moxifloxacin plus topical difluprednate 0.05% plus CXL

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 280
• Est. completion date: November 30, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Corneal ulcer that is smear positive and/or culture positive (within 24 hours) for typical bacteria (i.e. non-Nocardia or Mycobacteria)

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

• Corneal thickness =350 µm, as measured on AS-OCT

• Age over 18 years

• Basic understanding of the study as determined by the physician

• Commitment to return for follow up visits

Exclusion Criteria:

• Evidence of concomitant infection on exam, gram stain, or confocal microscopy (i.e. herpes, both bacteria and acanthameoba on gram stain)

• Impending or frank perforation at recruitment

• Involvement of sclera at presentation

• Non-infectious or autoimmune keratitis

• History of corneal transplantation or recent intraocular surgery

• Pinhole visual acuity worse than 20/200 in the unaffected eye

• Participants who are decisionally and/or cognitively impaired

Related Conditions & MeSH terms

• Keratitis
• Keratitis Bacterial

Intervention

Drug:
• Moxifloxacin Ophthalmic
Topical moxifloxacin 0.5% is a fluoroquinolone antibiotic that is used to treat bacterial infections. This is standard therapy for bacterial keratitis. Immediately after CXL/sham CXL and repeat culture, all participants will receive topical moxifloxacin drops every 1 hour for 2 days, and then every 2 hours while awake until resolution of the epithelial defect.
• Difluprednate Ophthalmic
Difluprednate 0.05% is a corticosteroid used to reduce inflammation in the eye. Participants will receive one drop of 0.05% difluprednate four times daily beginning 24 hours after the initiation of antibiotics for 1 week, decreased by 1 drop weekly for a total of 4 weeks of steroid therapy.
• Riboflavin Ophthalmic
All participants will receive a 30 minute loading dose of topical 0.1% riboflavin and 20% dextran T500 drops every 2 minutes. For participants randomized to corneal cross-linking(CXL), this will be followed by exposure to UV-A light at a wavelength of 365 nm with an irradiance of 3 mW/cm2 for 30 minutes for a total dose of 5.4 J/cm2 (UV lamp: PESCHKE Meditrade GmbH, Hueneberg, Switzerland for India; Avedro KXL System, Waltham, MA, USA for USA). During irradiation patients will continue to receive topical riboflavin at 5-minute intervals. For those randomized to sham CXL, this experience is simulated however the light will be shined adjacent to the patient, careful to avoid exposure to the cornea.

Other:
• Topical Placebo
Participants randomized to topical placebo will receive topical placebo on the same medication schedule as difluprednate: one drop of 0.05% difluprednate four times daily beginning 24 hours after the initiation of antibiotics for 1 week, decreased by 1 drop weekly for a total of 4 weeks of placebo therapy. Placebo will be the vehicle used in difluprednate.

Locations

Country	Name	City	State
India	Aravind Eye Care System	Madurai	Tamil Nadu
United States	University of Miami	Miami	Florida
United States	Francis I. Proctor Foundaiton	San Francisco	California

Sponsors (5)

Lead Sponsor	Collaborator
Thomas M. Lietman	Aravind Eye Care System, National Eye Institute (NEI), Stanford University, University of Miami

Countries where clinical trial is conducted

United States,  India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Best Spectacle-Corrected Visual Acuity	Best Spectacle-Corrected Visual Acuity	6 Months
Secondary	Best Spectacle-Corrected Visual Acuity	Best Spectacle-Corrected Visual Acuity	3 Weeks, 3 Months, 12 Months
Secondary	Number of Ulcers Testing Positive for Bacteria on Repeat Culture	Microbiological cure on repeat culture: A scraping of the corneal ulcer taken at 48 hours, then swabbed onto a culture plate and assessed for bacteria	2 Days
Secondary	Scar Size	Geometric Mean	3 Weeks, 3 Months, 6 Months 12 Months
Secondary	Scar Depth	Geometric Mean	3 Weeks, 3 Months, 6 Months, 12 Months
Secondary	Adverse Events	Adverse Events	12 Months