Actively Recruiting

Phase Not Applicable
Age: 20Years +
All Genders
NCT07394257

Intrastromal Moxifloxacin as an Adjunctive Therapy in Recalcitrant Bacterial Keratitis

Led by Minia University · Updated on 2026-02-06

60

Participants Needed

1

Research Sites

26 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Intrastromal Moxifloxacin as an Adjunctive Therapy in Recalcitrant Bacterial Keratitis

Who Can Participate

Age: 20Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Clinical diagnosis of bacterial keratitis confirmed by corneal scraping and microbiology
  • Recalcitrant keratitis with no significant improvement after 48-72 hours of intensive topical antibiotic therapy
  • Ability to provide written informed consent
Not Eligible

You will not qualify if you...

  • Fungal, viral, or acanthamoeba keratitis
  • Corneal perforation or risk of perforation
  • Known allergy to fluoroquinolone antibiotics
  • Pregnancy or breastfeeding
  • Immunocompromised condition or current use of systemic immunosuppressive drugs
  • Previous intrastromal or intracameral antibiotic injection for the same infection episode

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Mahmoud Ramadan Amer

Minya, Egypt

Actively Recruiting

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Research Team

M

Mahmoud Ramadan Amer, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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