Bacterial KeratitisNCT07394257
Intrastromal Moxifloxacin as an Adjunctive Therapy in Recalcitrant Bacterial Keratitis
A study testing Intrastromal moxifloxacin injection plus standard topical moxifloxacin therapy and Standard topical moxifloxacin therapy alone in people with Bacterial Keratitis and Recalcitrant Infectious Keratitis, run by Minia University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Bacterial Keratitis, Recalcitrant Infectious Keratitis, Corneal Ulcer
- What is being tested?
- Intrastromal moxifloxacin injection plus standard topical moxifloxacin therapy and Standard topical moxifloxacin therapy alone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2025to 1 Oct 2026
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
- Being tested
- Intrastromal moxifloxacin injection plus standard topical moxifloxacin therapy, Standard topical moxifloxacin therapy alone
- Medical subject headings
- Corneal Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrastromal moxifloxacin injection plus standard topical moxifloxacin therapyDrug
Intrastromal injection of preservative-free moxifloxacin 0.5% using a 30-gauge needle under aseptic conditions.
Standard topical moxifloxacin therapy aloneDrug
Intensive topical moxifloxacin eye drops every 1-2 hours initially, tapered according to standard clinical protocol and response.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Drug: Standard topical moxifloxacin therapy alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: weekly till complete healing
Secondary outcomes (5)
• Epithelial defect size(mm)
epithelial defect is measured by surgical caliper
Measured: weekly for one month
Hypopyon height(mm).
Measured: weekly for one month
Pain score on visual Analog scale (VAS, 1 - 10).
Measured: weekly for one month
Best-corrected visual acuity (BCVA) (LogMAR or Snellen)
Measured: weekly for one month
Complications (perforation, thinning, endophthalmitis).
Measured: after 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study start1 Oct 2025
- Primary completion1 Apr 2026
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bacterial KeratitisStudies of the same condition, open and under way.
- More trials run by Minia 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Ramadan, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07394257
- Sponsor's protocol ID
- 1827
- Status last verified
- Sep 2026
- First submitted
- 19 Jan 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: (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.
Publications
Zemba M, Radu M, Istrate S, Dumitrescu OM, Ionescu MA, Vatafu A, Barac IR. Intrastromal Injections in the Management of Infectious Keratitis. Pharmaceutics. 2023 Mar 29;15(4):1091. doi: 10.3390/pharmaceutics15041091.
PubMed 37111577
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intrastromal Moxifloxacin as an Adjunctive Therapy in Recalcitrant Bacterial Keratitis
- ClinicalTrials.gov ID
- NCT07394257
- Acronym / sponsor ID
- 1827
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 1 Apr 2026 (actual)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 6 Feb 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intrastromal moxifloxacin injection plus standard topical moxifloxacin therapy | Experimental | Drug: Intrastromal moxifloxacin injection plus standard topical moxifloxacin therapyIntrastromal injection of preservative-free moxifloxacin 0.5% using a 30-gauge needle under aseptic conditions. |
| Standard topical moxifloxacin therapy alone | Experimental | Drug: Standard topical moxifloxacin therapy alone• Intensive topical moxifloxacin eye drops every 1-2 hours initially, tapered according to standard clinical protocol and response |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- • Age ≥ 18 years
Key exclusion criteria (6 listed)
- Fungal, viral, or acanthamoeba keratitis
- Corneal perforation or impending perforation
- Known hypersensitivity to fluoroquinolones
- Pregnancy or lactation
- Immunocompromised state or current systemic immunosuppressive therapy
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 |
|---|---|---|
| Intrastromal moxifloxacin injection plus standard topical moxifloxacin therapyIntrastromal 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 aloneIntensive topical moxifloxacin eye drops every 1-2 hours initially, tapered according to standard clinical protocol and response. | Drug | Standard topical moxifloxacin therapy alone |
Primary outcome
Time to complete clinical resolution(days)
Time frame: weekly till complete healing
Time to complete clinical resolution, defined as corneal re-epithelialization with disappearance of stromal infiltrate and anterior chamber reaction.
5 secondary outcomes
• Epithelial defect size(mm)
Time frame: weekly for one month
Hypopyon height(mm).
Time frame: weekly for one month
Pain score on visual Analog scale (VAS, 1 - 10).
Time frame: weekly for one month
Best-corrected visual acuity (BCVA) (LogMAR or Snellen)
Time frame: weekly for one month
Complications (perforation, thinning, endophthalmitis).
Time frame: after 3 months
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 10 Sep 2026.
- Background: PubMed 37111577Zemba M, Radu M, Istrate S, Dumitrescu OM, Ionescu MA, Vatafu A, Barac IR. Intrastromal Injections in the Management of Infectious Keratitis. Pharmaceutics. 2023 Mar 29;15(4):1091. doi: 10.3390/pharmaceutics15041091.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. (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.
Related trials for Bacterial Keratitis
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Effect of Sodium Chloride 5% Solution as an Adjuvant Treatment With Antimicrobial Therapy in the Treatment of Bacterial Infectious Keratitis
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intrastromal moxifloxacin injection plus standard topical moxifloxacin therapy and Standard topical moxifloxacin therapy alone in people with Bacterial Keratitis and Recalcitrant Infectious Keratitis, run by Minia University at 1 site in Egypt.
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 4 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: looking for participants now, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Mahmoud Ramadan Amer, MD (0201068005575, mahmoud3mer89@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to complete clinical resolution(days) (time frame: weekly till complete healing). 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 NCT07394257, which also lists 1 linked publication.
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 10 Sep 2026.