Swiss PACK-CXL Multicenter Trial for the Treatment of Infectious Keratitis

• Status: Completed
• Trial end date: 2020-10-01
• Target enrollment: 0
• Participant gender: All

Summary

To assess the safety and efficacy of PACK-CXL (photoactivated chromophore for infectious keratitis cross-linking) as a firstline treatment for infectious corneal infiltrates and early corneal ulcers, and compare it to the current standard of care, antimicrobial therapy.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Geneva
• Treatments: 7-(3-aminohexahydro-1H-azepin-1-yl)-8-chloro-1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-3-quinolinecarboxylic acid; Anti-Infective Agents; Besifloxacin; Cefazolin; Ciprofloxacin; Cyclopentolate; Fluoroquinolones; Gatifloxacin; Gentamicins; Levofloxacin; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Moxifloxacin; Mydriatics; Norgestimate, ethinyl estradiol drug combination; Ofloxacin; Ophthalmic Solutions; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Tetrahydrozoline; Tobramycin

Criteria

Inclusion Criteria:

• Patient exhibit clinical signs of corneal infiltrate or beginning corneal ulcer on at least one eye, of suspected bacterial, fungal or mixed (bacterial and fungal) origin.

• Infiltrates and early ulcers up to a maximum 2mm in diameter; may lie close to the corneal limbus, but at a minimal distance of 2mm from central cornea.

• Infiltrates and early ulcer depth of a maximum of 300 μm, assessed by either OCT or Scheimpflug imaging

• All lesions must show an open epithelium with fluorescein positive staining

• No previous antibiotic/antifungal treatment OR at least no antibiotic/antifungal treatment for a minimum of 48 hours from last treatment

• Provide signed and dated patient consent form

• Patient willing to comply with all study procedures and be available for the duration of the study

• Male or female, >18 years of age. No children or adolescents of 18 years and less of age will be included in this study.

Exclusion Criteria:

• Lesion/infiltrate involving the central 2mm diameter of the cornea

• Suspicion of non-infectious keratitis, viral or acanthamoeba keratitis or sterile infiltrate.

• Closed epithelium over the lesion

• Pachymetry of less than 400 microns at the thinnest point.

• Patients who cannot participate in the treatment or be monitored with frequent clinician controls as required in the study protocol.

• Corneal perforation

• Descemetocele

• Pregnancy or breastfeeding

• Active corneal herpetic disease

• Systemic treatment involving steroids

• Immunosuppressed/immune-compromised patients

• Patients with diagnosed eczema (or atopic dermatitis)

• Previous keratoplasty

• Patients with monocular vision