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.

Study Overview

• Status: Recruiting
• Conditions: Corneal Ulcer; Bacterial Keratitis; Recalcitrant Infectious Keratitis
• Intervention / Treatment: Drug: Intrastromal moxifloxacin injection plus standard topical moxifloxacin therapy; Drug: Standard topical moxifloxacin therapy alone

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mahmoud Ramadan Amer, MD; Phone Number: 0201068005575; Email: mahmoud3mer89@gmail.com

Study Locations

• Egypt
  • Minya, Egypt
    • Recruiting
    • Mahmoud Ramadan Amer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intrastromal moxifloxacin injection plus standard topical moxifloxacin therapy; Intrastromal injection of preservative-free moxifloxacin 0.5% using a 30-gauge needle under aseptic conditions.	Drug: Intrastromal moxifloxacin injection plus standard topical moxifloxacin therapy; Intrastromal injection of preservative-free moxifloxacin 0.5% using a 30-gauge needle under aseptic conditions.
Experimental: Standard topical moxifloxacin therapy alone; • Intensive topical moxifloxacin eye drops every 1-2 hours initially, tapered according to standard clinical protocol and response	Drug: Standard topical moxifloxacin therapy alone; Intensive topical moxifloxacin eye drops every 1-2 hours initially, tapered according to standard clinical protocol and response.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	weekly till complete healing

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
• Epithelial defect size(mm)	epithelial defect is measured by surgical caliper	weekly for one month
Hypopyon height(mm).		weekly for one month
Pain score on visual Analog scale (VAS, 1 - 10).		weekly for one month
Best-corrected visual acuity (BCVA) (LogMAR or Snellen)		weekly for one month
Complications (perforation, thinning, endophthalmitis).		after 3 months

Collaborators and Investigators

• Sponsor: Minia University

Publications and helpful links

General Publications

• Zemba M, et al. Intrastromal injections in infectious keratitis. Pharmaceutics. 2023

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2025
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: January 19, 2026
• First Submitted That Met QC Criteria: February 1, 2026
• First Posted (Actual): February 6, 2026

Study Record Updates

• Last Update Posted (Actual): February 6, 2026
• Last Update Submitted That Met QC Criteria: February 1, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Eye Diseases; Corneal Diseases; Keratitis; Eye Infections; Corneal Ulcer
• Other Study ID Numbers: 1827

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: (IPD) will not be shared because the study was not designed with a data-sharing framework, and participants did not provide explicit consent for secondary use or external sharing of their individual-level data. In addition, sharing IPD may pose potential risks to participant privacy, even after de-identification, particularly in single-center studies with limited sample sizes. Current clinical trial registration requirements mandate transparency regarding data-sharing intentions but do not obligate investigators to share IPD. Therefore, the decision not to share IPD is made in accordance with ethical standards, privacy regulations, and applicable registry policies.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No