Intrastromal Injection of Fluconazole in Treatment of Fungal Keratitis

April 23, 2026 updated by: Mohamed Ramadan Taha Sharaf Eldin, Tanta University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

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 Locations

  • Egypt
    • El-Gharbia
      • Tanta, El-Gharbia, Egypt, 31527
        • Tanta University

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
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients diagnosed both clinically and laboratory as fungal keratitis.
  • Fungal cultures should be sensitive to fluconazole.

Exclusion Criteria:

  • 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.

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: Group A
Eyes that received treatment as topical fluconazole eye drops
Drug: Topical fluconazole eye drops
Eyes that received treatment as topical fluconazole eye drops
Experimental: Group B
Eyes that received treatment as intrastromal injection of fluconazole.
Drug: Intrastromal injection of fluconazole
Eyes that received treatment as intrastromal injection of fluconazole.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Every three days until complete healing (Up to 6 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Uncorrected visual acuity
Time Frame: Every three days until complete healing (Up to 6 weeks)
Uncorrected visual acuity was recorded and described by LogMAR notation.
Every three days until complete healing (Up to 6 weeks)
Duration of healing
Time Frame: 6 weeks post-procedure
Duration of healing was recorded.
6 weeks post-procedure

Collaborators and Investigators

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

Sponsor

Tanta University

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 (Actual)

January 1, 2022

Primary Completion (Actual)

December 1, 2022

Study Completion (Actual)

December 1, 2022

Study Registration Dates

First Submitted

April 23, 2026

First Submitted That Met QC Criteria

April 23, 2026

First Posted (Actual)

April 30, 2026

Study Record Updates

Last Update Posted (Actual)

April 30, 2026

Last Update Submitted That Met QC Criteria

April 23, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • 35010/10/21

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

IPD Sharing Time Frame

After the end of study for one year.

IPD Sharing Access Criteria

The data will be available upon a reasonable request from the corresponding author.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

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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