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
This trial does not accept healthy volunteersQualifiers
• 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
Parallel
Treatments tested in this trial
Intrastromal moxifloxacin injection plus standard topical moxifloxacin therapy
DrugIntrastromal injection of preservative-free moxifloxacin 0.5% using a 30-gauge needle under aseptic conditions.
Standard topical moxifloxacin therapy alone
DrugIntensive topical moxifloxacin eye drops every 1-2 hours initially, tapered according to standard clinical protocol and response.
Treatment groups
Trial outcomes
Primary outcomes
Time to complete clinical resolution(days)
Time to complete clinical resolution, defined as corneal re-epithelialization with disappearance of stromal infiltrate and anterior chamber reaction.
Secondary outcomes
• Epithelial defect size(mm)
epithelial defect is measured by surgical caliper
Hypopyon height(mm).
Pain score on visual Analog scale (VAS, 1 - 10).
Best-corrected visual acuity (BCVA) (LogMAR or Snellen)
Sponsors and contacts
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