NCT06757907

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2024

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 25, 2024

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

December 27, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 3, 2025

Completed
Last Updated

January 3, 2025

Status Verified

December 1, 2024

Enrollment Period

3 months

First QC Date

December 27, 2024

Last Update Submit

December 27, 2024

Conditions

Herpetic Keratitis

Keywords

acyclovirganciclovir

Outcome Measures

Primary Outcomes (1)

  • Corneal healing

    Heling of the keratitis

    At 4 and 6 weeks

Secondary Outcomes (1)

  • Sie effects

    at 4 and 6 weeks

Study Arms (2)

ganciclovir

ACTIVE COMPARATOR
Drug: Ganciclovir (GCV)

Systemic acyclovir

ACTIVE COMPARATOR
Drug: Acyclovir 400 MG

Interventions

Acyclovir 400 MGDRUG

Acyclovir is used to treat infections caused by certain types of viruses.

Systemic acyclovir
Ganciclovir (GCV)DRUG

Ganciclovir is an anti-viral drug

ganciclovir

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients diagnosed with herpetic keratitis

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al-Azhar university

Damietta, Egypt

Location

MeSH Terms

Conditions

Keratitis, HerpeticMultiple Acyl Coenzyme A Dehydrogenase Deficiency

Interventions

AcyclovirGanciclovir

Condition Hierarchy (Ancestors)

Eye Infections, ViralEye InfectionsInfectionsHerpes SimplexHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesKeratitisCorneal DiseasesEye DiseasesAmino Acid Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMetabolic DiseasesNutritional and Metabolic DiseasesMitochondrial Diseases

Intervention Hierarchy (Ancestors)

GuanineHypoxanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 27, 2024

First Posted

January 3, 2025

Study Start

October 1, 2024

Primary Completion

December 20, 2024

Study Completion

December 25, 2024

Last Updated

January 3, 2025

Record last verified: 2024-12

Locations

EG(1)