Steroids and Cross-linking for Ulcer Treatment (SCUT II)

Thomas M. Lietman

Status and phase: Completed; Phase 3

Conditions: Keratitis Bacterial

Treatments: Drug: Moxifloxacin Ophthalmic; Other: Topical Placebo; Drug: Riboflavin Ophthalmic; Drug: Difluprednate Ophthalmic

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04097730

UG1EY028518 (U.S. NIH Grant/Contract)

18-26045

Details and patient eligibility

About

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

Enrollment: 280 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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280 participants in 3 patient groups, including a placebo group

Standard Therapy

Placebo Comparator group

Description:

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

Treatment:

Other: Topical Placebo

Drug: Riboflavin Ophthalmic

Drug: Moxifloxacin Ophthalmic

Early Steroids

Experimental group

Description:

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

Treatment:

Drug: Difluprednate Ophthalmic

Drug: Moxifloxacin Ophthalmic

Cross-Linking plus Early Steroids

Experimental group

Description:

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

Treatment:

Drug: Difluprednate Ophthalmic

Drug: Riboflavin Ophthalmic

Drug: Moxifloxacin Ophthalmic