Effect of Sodium Chloride 5% Solution as an Adjuvant Treatment With Antimicrobial Therapy in the Treatment of Bacterial Infectious Keratitis (keratitis)

March 2, 2026 updated by: Nancy Safwat Kaldes, Sohag University
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Prospective randomized control study 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.Data study will include two groups classified as follow : the first group will include treatment of microbial keratitis by antibiotic with sodium chloride 5% , the second group will include treatment by antibiotic only

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Amr Mounir Mohamed, Assistant professor
  • Phone Number: 01005026170

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

IncluInclusion Criteria

  • 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

Exclusion Criteria:

  • • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
treatment of microbial keratitis by antibiotic with sodium chloride 5%
Drug: Sodium chloride 5% solution
Use Sodium chloride 5% solution with usual anti microbial drugs
Drug: quinolones
Use of usual topical anti microbial treatment only
Active Comparator: Control group
Treatment of microbial keratitis by antibiotics only
Drug: quinolones
Use of usual topical anti microbial treatment only

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Control of infection
Time Frame: 6 months
Improvement of manifestation according to rate of healing
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2026

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

February 1, 2027

Study Registration Dates

First Submitted

February 19, 2026

First Submitted That Met QC Criteria

March 2, 2026

First Posted (Actual)

March 5, 2026

Study Record Updates

Last Update Posted (Actual)

March 5, 2026

Last Update Submitted That Met QC Criteria

March 2, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-Med--26-2-2MD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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