Intrastromal Moxifloxacin as an Adjunctive Therapy in Recalcitrant Bacterial Keratitis

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20+
SponsorMinia University

About this trial

Bacterial keratitis is a potentially sight-threatening corneal infection that is commonly treated with intensive topical antibiotics. Despite appropriate therapy, some cases show inadequate clinical response, particularly when the infection involves the deep corneal stroma. Limited penetration of topical antibiotics into deeper corneal layers may contribute to treatment failure in these recalcitrant cases.

Intrastromal antibiotic injection is a targeted drug-delivery approach that allows high local antimicrobial concentrations directly at the site of infection. Moxifloxacin is a broad-spectrum fluoroquinolone with proven efficacy in bacterial keratitis and favorable corneal tissue penetration. However, evidence regarding the clinical benefit and safety of intrastromal moxifloxacin as an adjunctive treatment remains limited.

This randomized controlled trial aims to evaluate the efficacy and safety of intrastromal moxifloxacin injection as an adjunct to standard topical moxifloxacin therapy compared with topical therapy alone in patients with recalcitrant bacterial keratitis. The primary outcome is time to complete clinical resolution of infection. Secondary outcomes include visual acuity improvement, ulcer healing rate, need for additional interventions, and treatment-related complications.

Eligibility criteria

Qualifiers

• Age ≥ 18 years

Clinical diagnosis of bacterial keratitis confirmed by corneal scraping and microbiology

Recalcitrant keratitis defined as no significant clinical improvement after 48-72 hours of intensive topical antibiotic therapy

Ability to provide written informed consent

Disqualifiers

Fungal, viral, or acanthamoeba keratitis

Corneal perforation or impending perforation

Known hypersensitivity to fluoroquinolones

Pregnancy or lactation

Trial design

Treatments tested in this trial

  • Intrastromal moxifloxacin injection plus standard topical moxifloxacin therapy
  • Standard topical moxifloxacin therapy alone

Treatment groups

60 Participants
are divided into 2 treatment groups

Sponsors and collaborators