Topical Ganciclovir Versus Systemic Aciclovir in the Treatment of Herpetic Keratitis

December 27, 2024 updated by: Ehab Tharwat, Al-Azhar University
Traditional antiviral treatments, including systemic acyclovir, have shown effectiveness in resolving keratitis but can also lead to complications, including ocular surface toxicity and the development of acyclovir-resistant strains of HSV. Topical ganciclovir 0.15% ophthalmic gel presents a safer alternative for managing herpetic keratitis, offering effective viral suppression with minimal toxicity. This study aims to compare the efficacy and safety of topical ganciclovir versus systemic acyclovir in treating herpetic keratitis, providing valuable insights into optimal management strategies for this condition

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

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
      • Damietta, Egypt
        • Al-Azhar 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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients diagnosed with herpetic keratitis

Exclusion Criteria:

  • Patients with known allergies to ganciclovir or acyclovir
  • Severe ocular surface disease
  • Those who have previously received antiviral therapy for herpetic keratitis within the last month

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
Active Comparator: ganciclovir
Drug: Ganciclovir (GCV)
Ganciclovir is an anti-viral drug
Active Comparator: Systemic acyclovir
Drug: Acyclovir 400 MG
Acyclovir is used to treat infections caused by certain types of viruses.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Corneal healing
Time Frame: At 4 and 6 weeks
Heling of the keratitis
At 4 and 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sie effects
Time Frame: at 4 and 6 weeks
Measuring the percentage of the side effects of the drugs
at 4 and 6 weeks

Collaborators and Investigators

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

Sponsor

Al-Azhar 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)

October 1, 2024

Primary Completion (Actual)

December 20, 2024

Study Completion (Actual)

December 25, 2024

Study Registration Dates

First Submitted

December 27, 2024

First Submitted That Met QC Criteria

December 27, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 27, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Herpetic Keratitis

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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