A Phase 3 interventional study of Moxifloxacin Ophthalmic and Difluprednate Ophthalmic in Keratitis Bacterial, sponsored by Thomas M. Lietman. Completed at 3 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-03.
Sponsored by Thomas M. Lietman · Phase 3, Interventional, and Treatment
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
108 studies on the registry are indexed under Keratitis; 19 are open to participants now.
This study's enrollment of 280 is above the median of 40 across 70 interventional studies indexed under Keratitis.
Browse Keratitis studies →Thomas M. Lietman is the lead sponsor of 3 studies on the registry; none are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in this arm will receive topical 0.5% moxifloxacin plus topical placebo plus sham corneal cross-linking.
Drug: Moxifloxacin Ophthalmic · Drug: Riboflavin Ophthalmic · Other: Topical Placebo
Participants in this arm will receive topical 0.5% moxifloxacin plus topical steroids plus sham corneal cross-linking.
Drug: Moxifloxacin Ophthalmic · Drug: Difluprednate Ophthalmic
Participants in this group will receive topical 0.5% moxifloxacin plus topical steroids plus corneal cross-linking.
Drug: Moxifloxacin Ophthalmic · Drug: Difluprednate Ophthalmic · Drug: Riboflavin 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 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.
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.
Also known as: Corneal Cross-Linking with Riboflavin Ophthalmic
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.
Best Spectacle-Corrected Visual Acuity
Best Spectacle-Corrected Visual Acuity
Time frame: 6 Months
Best Spectacle-Corrected Visual Acuity
Best Spectacle-Corrected Visual Acuity
Time frame: 3 Weeks, 3 Months, 12 Months
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
Time frame: 2 Days
Scar Size
Geometric Mean
Time frame: 3 Weeks, 3 Months, 6 Months 12 Months
Scar Depth
Geometric Mean
Time frame: 3 Weeks, 3 Months, 6 Months, 12 Months
Adverse Events
Adverse Events
Time frame: 12 Months
Plan to share: No
Ran from Sep 2020 to primary completion in May 2024, 43 months.
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Thomas M. Lietman