RecruitingNot ApplicableNCT07394257

Intrastromal Moxifloxacin as an Adjunctive Therapy in Recalcitrant Bacterial Keratitis


Sponsor

Minia University

Enrollment

60 participants

Start Date

Oct 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 20 Years

Inclusion Criteria4

  • • 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

Exclusion Criteria6

  • 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

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Interventions

DRUGIntrastromal moxifloxacin injection plus standard topical moxifloxacin therapy

Intrastromal injection of preservative-free moxifloxacin 0.5% using a 30-gauge needle under aseptic conditions.

DRUGStandard topical moxifloxacin therapy alone

Intensive topical moxifloxacin eye drops every 1-2 hours initially, tapered according to standard clinical protocol and response.


Locations(1)

Mahmoud Ramadan Amer

Minya, Egypt

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NCT07394257


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