Infectious KeratitiskeratitisNCT07452588
Effect of Sodium Chloride 5% Solution as an Adjuvant Treatment With Antimicrobial Therapy in the Treatment of Bacterial Infectious Keratitis
A study testing Sodium chloride 5% solution and quinolones in people with Infectious Keratitis and Adjuvant Treatment Bacterial Infectious Keratitis, run by Sohag University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Infectious Keratitis, Adjuvant Treatment Bacterial Infectious Keratitis, Sodium Chloride 5% Solution
- What is being tested?
- Sodium chloride 5% solution and quinolones
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Feb 2026to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
None listed.
Who cannot join
- • 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Amr Mounir Mohamed, Assistant professor contact
About this study
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.
Read the 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
- Conditions
- Infectious Keratitis, Adjuvant Treatment Bacterial Infectious Keratitis, Sodium Chloride 5% Solution
- Being tested
- Sodium chloride 5% solution, quinolones
- Keywords
- Bacterial infectious keratitis, Sodiunchloride5%
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium chloride 5% solutionDrug
Use Sodium chloride 5% solution with usual anti microbial drugs
quinolonesDrug
Use of usual topical anti microbial treatment only
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | treatment of microbial keratitis by antibiotic with sodium chloride 5% Receives: Drug: Sodium chloride 5% solution; Drug: quinolones |
| Control group | Active comparator | Treatment of microbial keratitis by antibiotics only Receives: Drug: quinolones |
What is being measured
The primary outcome is the main question the study is designed to answer.
Control of infection
Improvement of manifestation according to rate of healing
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2026
- Study startFeb 2026 (estimated)
- Primary completionAug 2026 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Infectious KeratitisStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nancy Safwat Kaldes, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07452588
- Sponsor's protocol ID
- Soh-Med--26-2-2MD
- Acronym
- keratitis
- Status last verified
- Mar 2026
- First submitted
- 19 Feb 2026
- Last updated
- 5 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 Ophthalmol. 2019 Apr-Jun;63(2):119-127.
PubMed 31334389Ung L, Bispo PJM, Shanbhag SS, Gilmore MS, Chodosh J. The persistent dilemma of microbial keratitis: Global burden, diagnosis, and antimicrobial resistance. Surv Ophthalmol. 2019 May-Jun;64(3):255-271. doi: 10.1016/j.survophthal.2018.12.003. Epub 2018 Dec 24.
PubMed 30590103
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Sodium Chloride 5% Solution as an Adjuvant Treatment With Antimicrobial Therapy in the Treatment of Bacterial Infectious Keratitis
- ClinicalTrials.gov ID
- NCT07452588
- Acronym / sponsor ID
- keratitis / Soh-Med--26-2-2MD
- Conditions
- Infectious Keratitis, Adjuvant Treatment Bacterial Infectious Keratitis, Sodium Chloride 5% Solution
- Keywords
- Bacterial infectious keratitis, Sodiunchloride5%
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- Feb 2026 (estimated)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 5 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Drug: Sodium chloride 5% solution, Drug: quinolonestreatment of microbial keratitis by antibiotic with sodium chloride 5% |
| Control group | Active comparator | Drug: quinolonesTreatment of microbial keratitis by antibiotics only |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- • Fungal, viral, or acanthamoeba keratitis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sodium chloride 5% solutionUse Sodium chloride 5% solution with usual anti microbial drugs | Drug | Intervention group |
| quinolonesUse of usual topical anti microbial treatment only | Drug | Control group, Intervention group |
Primary outcome
Control of infection
Time frame: 6 months
Improvement of manifestation according to rate of healing
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
- Background9. 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: PubMed 31334389Acharya M, Farooqui JH, Jain S, Mathur U. Pearls and paradigms in Infective Keratitis. Rom J Ophthalmol. 2019 Apr-Jun;63(2):119-127.
- Background: PubMed 30590103Ung L, Bispo PJM, Shanbhag SS, Gilmore MS, Chodosh J. The persistent dilemma of microbial keratitis: Global burden, diagnosis, and antimicrobial resistance. Surv Ophthalmol. 2019 May-Jun;64(3):255-271. doi: 10.1016/j.survophthal.2018.12.003. Epub 2018 Dec 24.
- Individual participant dataSharing planned: No
Related trials for Infectious Keratitis
RecruitingObservational study
Validation of Interleukins and Other Cytokines Together With OCT Imaging for Rapid Infectious Keratitis Assessment
Keratitis Bacterial, Keratitis Fungal
Recruiting
Intrastromal Moxifloxacin as an Adjunctive Therapy in Recalcitrant Bacterial Keratitis
Bacterial Keratitis, Recalcitrant Infectious Keratitis
Active, not recruitingPhase 3
Rose Bengal Electromagnetic Activation With Green Light for Infection Reduction II
Bacterial Keratitis
Not yet recruitingPhase 3
RB-PDT for Fusarium Keratitis: The LUMIERE Study
Fusarium Keratitis
RecruitingObservational study
Proteomic and Metabolomic Lacrimal Fingerprint in Diverse Pathologies of the Ocular Surface
Dry Eye Syndrome, Infectious Keratoconjunctivitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Amr Mounir Mohamed, Assistant professor contact
Questions about this trial
What is this clinical trial studying?
A study testing Sodium chloride 5% solution and quinolones in people with Infectious Keratitis and Adjuvant Treatment Bacterial Infectious Keratitis, run by Sohag University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nancy Safwat Kaldas, Specialist (01200933440, nansy_safwat_post@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Control of infection (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07452588, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026.