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
Phase:
Phase 3
Details
Lead Sponsor:
Thomas M. Lietman
Collaborators:
Aravind Eye Care System Kaiser Permanente National Eye Institute (NEI) Stanford University University of Miami
Treatments:
Difluprednate Moxifloxacin Norgestimate, ethinyl estradiol drug combination Riboflavin