Intrastromal Moxifloxacin as an Adjunctive Therapy in Recalcitrant Bacterial Keratitis

NCT07394257 | Recruiting DMC

• 1 other identifier: 1827
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Corneal Ulcer; Bacterial Keratitis; Recalcitrant Infectious Keratitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• • Epithelial defect size(mm)

  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

Study Arms (2)

Intrastromal moxifloxacin injection plus standard topical moxifloxacin therapy

EXPERIMENTAL

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

Standard topical moxifloxacin therapy alone

EXPERIMENTAL

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

Drug: Standard topical moxifloxacin therapy alone

Interventions

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.

Intrastromal moxifloxacin injection plus standard topical moxifloxacin therapy

Standard topical moxifloxacin therapy alone DRUG

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

Standard topical moxifloxacin therapy alone

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Minia University: lead

Study Sites (1)

Mahmoud Ramadan Amer

Minya, Egypt

RECRUITING

Related Publications (1)

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

  BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Corneal Ulcer

Condition Hierarchy (Ancestors)

Eye Infections; Infections; Keratitis; Corneal Diseases; Eye Diseases

Central Study Contacts

Mahmoud Ramadan Amer, MD

CONTACT

0201068005575; mahmoud3mer89@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Randomization will be performed using a computer-generated random sequence. Allocation will be concealed using sealed opaque envelopes.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of ophthalmology

Study Record Dates

• First Submitted: January 19, 2026
• First Posted: February 6, 2026
• Study Start: October 1, 2025
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: February 6, 2026

Record last verified: 2026-02

Locations

EG (1)