SafetyNCT07557966
Intrastromal Injection of Fluconazole in Treatment of Fungal Keratitis
A study testing Topical fluconazole eye drops and Intrastromal injection of fluconazole in people with Safety and Efficacy, run by Tanta University at 1 site in Egypt.
Trial summary
This study aimed to evaluate the Safety and the Effectiveness of Intrastromal Injection of Fluconazole in The Treatment of Fungal Keratitis. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Safety, Efficacy, Intrastromal Injection
- What is being tested?
- Topical fluconazole eye drops and Intrastromal injection of fluconazole
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2022to 1 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed both clinically and laboratory as fungal keratitis.
- Fungal cultures should be sensitive to fluconazole.
Who cannot join
- Thin cornea.
- Decmatocele.
- Necrotic or perforated corneal ulcers.
- Other types of keratitis (bacterial or viral).
- Fungal cultures resistant to fluconazole.
- Patients on immune-suppressants drugs.
- Silicon oil filled eyes.
- Previous ocular surgery e.g keratoplasty.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of the Safety and Efficacy of Intrastromal Injection of Fluconazole in Treatment of Fungal Keratitis
This study aimed to evaluate the Safety and the Effectiveness of Intrastromal Injection of Fluconazole in The Treatment of Fungal Keratitis.
Read the detailed description
Fungal keratitis is one of the most challenging types of infectious keratitis. It now accounts for approximately 50% of infectious corneal diseases, and corneal blindness has become the second leading cause of blindness in developing countries.
The potentially poor prognosis may be due to a delay in diagnosis and / or to limited effective antifungal agents that leads to decrease visual acuity and blindness.
Fluconazole is mainly a fungistatic drug with broad spectrum activity as it is effective against Yeast \& Dermatophytes (Candida, Cryptococcus neoformans \& Aspergillus species) Fluconazole is stable and a water-soluble small molecule with high bioavailability and low toxicity.
- Conditions
- Safety, Efficacy, Intrastromal Injection, Fluconazole, Treatment, Fungal Keratitis
- Being tested
- Topical fluconazole eye drops, Intrastromal injection of fluconazole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical fluconazole eye dropsDrug
Eyes that received treatment as topical fluconazole eye drops
Intrastromal injection of fluconazoleDrug
Eyes that received treatment as intrastromal injection of fluconazole.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Eyes that received treatment as topical fluconazole eye drops Receives: Drug: Topical fluconazole eye drops |
| Group B | Experimental | Eyes that received treatment as intrastromal injection of fluconazole. Receives: Drug: Intrastromal injection of fluconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best-corrected visual acuity
Best-corrected visual acuity (BCVA) was recorded and described by LogMAR notation.
Measured: Every three days until complete healing (Up to 6 weeks)
Secondary outcomes (2)
Uncorrected visual acuity
Uncorrected visual acuity was recorded and described by LogMAR notation.
Measured: Every three days until complete healing (Up to 6 weeks)
Duration of healing
Duration of healing was recorded.
Measured: 6 weeks post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2026
- Study start1 Jan 2022
- Primary completion1 Dec 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SafetyStudies of the same condition, open and under way.
- More trials run by Tanta 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 (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ramadan Taha Sharaf Eldin, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07557966
- Sponsor's protocol ID
- 35010/10/21
- Status last verified
- Apr 2026
- First submitted
- 23 Apr 2026
- Last updated
- 30 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Safety and Efficacy of Intrastromal Injection of Fluconazole in Treatment of Fungal Keratitis
- ClinicalTrials.gov ID
- NCT07557966
- Acronym / sponsor ID
- 35010/10/21
- Conditions
- Safety, Efficacy, Intrastromal Injection, Fluconazole, Treatment, Fungal Keratitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 30 Apr 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 aimed to evaluate the Safety and the Effectiveness of Intrastromal Injection of Fluconazole in The Treatment of Fungal Keratitis.
Detailed description
Fungal keratitis is one of the most challenging types of infectious keratitis. It now accounts for approximately 50% of infectious corneal diseases, and corneal blindness has become the second leading cause of blindness in developing countries.
The potentially poor prognosis may be due to a delay in diagnosis and / or to limited effective antifungal agents that leads to decrease visual acuity and blindness.
Fluconazole is mainly a fungistatic drug with broad spectrum activity as it is effective against Yeast \& Dermatophytes (Candida, Cryptococcus neoformans \& Aspergillus species) Fluconazole is stable and a water-soluble small molecule with high bioavailability and low toxicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: Topical fluconazole eye dropsEyes that received treatment as topical fluconazole eye drops |
| Group B | Experimental | Drug: Intrastromal injection of fluconazoleEyes that received treatment as intrastromal injection of fluconazole. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients diagnosed both clinically and laboratory as fungal keratitis.
- Fungal cultures should be sensitive to fluconazole.
Key exclusion criteria (8 listed)
- Thin cornea.
- Decmatocele.
- Necrotic or perforated corneal ulcers.
- Other types of keratitis (bacterial or viral).
- Fungal cultures resistant to fluconazole.
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 |
|---|---|---|
| Topical fluconazole eye dropsEyes that received treatment as topical fluconazole eye drops | Drug | Group A |
| Intrastromal injection of fluconazoleEyes that received treatment as intrastromal injection of fluconazole. | Drug | Group B |
Primary outcome
Best-corrected visual acuity
Time frame: Every three days until complete healing (Up to 6 weeks)
Best-corrected visual acuity (BCVA) was recorded and described by LogMAR notation.
2 secondary outcomes
Uncorrected visual acuity
Time frame: Every three days until complete healing (Up to 6 weeks)
Duration of healing
Time frame: 6 weeks post-procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Topical fluconazole eye drops and Intrastromal injection of fluconazole in people with Safety and Efficacy, run by Tanta 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 2 inclusion and 8 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: finished, as of the sponsor's last update on 30 Apr 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best-corrected visual acuity (time frame: Every three days until complete healing (Up to 6 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Apr 2026.