NCT07452588

Brief Summary

This study aims to detect the effect of sodium chloride 5% solution as an adjuvant treatment with antimicrobial therapy in treatment of bacterial infectious keratits and to assess whether NaCl 5% accelerates epithelial healing, improves microbial eradication, and enhances visual outcomes in bacterial infectious keratitis.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
6mo left

Started Feb 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress52%
Feb 2026Feb 2027

Study Start

First participant enrolled

February 1, 2026

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

February 19, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 5, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Expected
Last Updated

March 5, 2026

Status Verified

March 1, 2026

Enrollment Period

6 months

First QC Date

February 19, 2026

Last Update Submit

March 2, 2026

Conditions

Adjuvant Treatment Bacterial Infectious KeratitisSodium Chloride 5% SolutionInfectious Keratitis

Keywords

Bacterial infectious keratitisSodiunchloride5%

Outcome Measures

Primary Outcomes (1)

  • Control of infection

    Improvement of manifestation according to rate of healing

    6 months

Study Arms (2)

Intervention group

EXPERIMENTAL

treatment of microbial keratitis by antibiotic with sodium chloride 5%

Drug: Sodium chloride 5% solutionDrug: quinolones

Control group

ACTIVE COMPARATOR

Treatment of microbial keratitis by antibiotics only

Drug: quinolones

Interventions

Sodium chloride 5% solutionDRUG

Use Sodium chloride 5% solution with usual anti microbial drugs

Intervention group
quinolonesDRUG

Use of usual topical anti microbial treatment only

Control groupIntervention group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age ≥ 18 years.
  • Clinically diagnosed bacterial infectious keratitis
  • Positive corneal scraping or strong clinical suspicion of bacterial cause.
  • Ability to provide informed consent and attend follow-up visits

You may not qualify if:

  • Fungal, viral, or acanthamoeba keratitis.
  • Recent (\<7 days) topical corticosteroid use.
  • Corneal perforation or impending perforation.
  • History of hypersensitivity to study agents.
  • Systemic immunocompromised state (uncontrolled diabetes, Human immune defecinicy virus).
  • Poor compliance expected with follow-up.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 9. Davidson, P.; Taylor, T. Chemical Preservatives and Natural Antimicrobial Compounds. In Food Microbiology: Fundamentals and Frontiers, 3rd ed.; Wiley Online Library: New York, NY, USA, 2017; pp. 713-745

    BACKGROUND

  • Acharya M, Farooqui JH, Jain S, Mathur U. Pearls and paradigms in Infective Keratitis. Rom J Ophthalmology, 2019 Apr-Jun;63(2):119-127.

    BACKGROUND

  • Ung L, Bispo PJM, Shanbhag SS, Gilmore MS, Chodosh J. The persistent dilemma of microbial keratitis: Global burden, diagnosis, and antimicrobial resistance. Survey Ophthalmology. 2019 May-Jun;64(3):255-271

    BACKGROUND

MeSH Terms

Interventions

Sodium ChlorideSolutionsQuinolones

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsPharmaceutical PreparationsQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Central Study Contacts

Nancy Safwat Kaldas, Specialist

CONTACT

01200933440nansy_safwat_post@med.sohag.edu.eg

Amr Mounir Mohamed, Assistant professor

CONTACT

01005026170

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 19, 2026

First Posted

March 5, 2026

Study Start

February 1, 2026

Primary Completion

August 1, 2026

Study Completion (Estimated)

February 1, 2027

Last Updated

March 5, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share