Intrastromal Moxifloxacin as an Adjunctive Therapy in Recalcitrant Bacterial Keratitis

Recruiting now · Not applicable

Conditions studied: Bacterial Keratitis, Recalcitrant Infectious Keratitis, Corneal Ulcer

In brief

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.

Key facts

Study ID

NCT07394257

Run by

Minia University

People needed

60

Starts

2025-10-01

Expected to finish

2026-04-01

Last updated by the study team

2026-02-06

Who can join

Age: 20 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• • 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

You may not qualify if…

• Fungal, viral, or acanthamoeba keratitis
• Corneal perforation or impending perforation
• Known hypersensitivity to fluoroquinolones
• Pregnancy or lactation
• Immunocompromised state or current systemic immunosuppressive therapy
• Previous intrastromal or intracameral antibiotic injection for the same episode

Where it is running

• Mahmoud Ramadan Amer — Minya, Egypt (enrolling)

Full record on ClinicalTrials.gov

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