Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07394257

Intrastromal Moxifloxacin as an Adjunctive Therapy in Recalcitrant Bacterial Keratitis

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mahmoud Ramadan Amer

Minya, Egypt

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • • 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 criteria

  • 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

Treatment and study plan

Intrastromal moxifloxacin injection plus standard topical moxifloxacin therapy

Drug

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

Standard topical moxifloxacin therapy alone

Drug

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

Primary outcomes

  1. Time to complete clinical resolution(days)

    Time frame: weekly till complete healing

    Time to complete clinical resolution, defined as corneal re-epithelialization with disappearance of stromal infiltrate and anterior chamber reaction.

Secondary outcomes

  1. • Epithelial defect size(mm)

    Time frame: weekly for one month

    epithelial defect is measured by surgical caliper

  2. Hypopyon height(mm).

    Time frame: weekly for one month

  3. Pain score on visual Analog scale (VAS, 1 - 10).

    Time frame: weekly for one month

  4. Best-corrected visual acuity (BCVA) (LogMAR or Snellen)

    Time frame: weekly for one month

  5. Complications (perforation, thinning, endophthalmitis).

    Time frame: after 3 months

Study contacts

Contact information is provided by the study sponsor or research team.

Mahmoud Ramadan Amer, MD

CONTACT

[email protected]

0201068005575

Sponsors and collaborators

Lead sponsor

Minia University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 6, 2026
Registry last updated
Feb 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.