NCT05313828

Brief Summary

Eye infection is a prevalent problem in primary care and remains a crucial healthcare concern. According to the American Academy of Ophthalmology (AAO), herpes simplex virus (HSV) keratitis (HSK) is the leading cause of infectious blindness worldwide . HSK is defined as a corneal inflammatory condition caused by the HSV infection . The global incidence of herpetic keratitis is estimated at 1.5 million per year, resulting in 40,000 new cases of severe visual impairment associated with corneal scarring and opacification . HSV type I (HSV-1) is by far the most predominant causative pathogen of eye infections\]. HSV-1 is also known for causing orolabial herpes, HSV folliculitis, herpes gladiatorum, herpetic whitlow, and eczema herpeticum . HSV can be transferred to the eye by touching an active lesion and then the eye. The National Health and Nutrition Evaluation revealed a seroprevalence of HSV-1 in 53.9% of 14-49 year olds, and 90% of adults 50 years or older , indicating that the majority of the population has been exposed to this virus thus are at risk of developing HSK. In this study we evaluate the efficacy of different treatment modalities on viral keratitis HSK.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

March 18, 2022

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

March 26, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 6, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 28, 2022

Completed
22 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2022

Completed
Last Updated

April 6, 2022

Status Verified

April 1, 2022

Enrollment Period

3 months

First QC Date

March 26, 2022

Last Update Submit

April 4, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • healing of the epithelium

    the epithelial healing assessed with flourescin stain and measured by slit lamp scale in millimetres and compared with pre treatment epithelial defect

    10 days follow up

Study Arms (4)

group 1'

patients with viral ulcers will receive antiviral medication with antibiotics

Drug: AcyclovirDrug: Tobramycin

group 2

patients with viral ulcers will receive antiviral medication, tear substitutes with antibiotics

Drug: AcyclovirDrug: TobramycinDrug: Sodium Hyaluronate

group 3

patients with viral ulcers will receive antiviral medication, weak steroids(at the same time) with antibiotics

Drug: AcyclovirDrug: TobramycinDrug: Fluorometholone

group 4

patients with viral ulcers will receive antiviral medication with antibiotics followed by weak steroid after epithelial healing

Drug: AcyclovirDrug: TobramycinDrug: Fluorometholone

Interventions

acyclovir 4 times /day

group 1'group 2group 3group 4

tobramycin 4 times /day

group 1'group 2group 3group 4

Fluorometholone 4 times/ day

group 3group 4

Sodium Hyaluronate 4 times/day

group 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients suffering from epithelial viral keratitis

You may qualify if:

  • patients with epithelial viral ulcers

You may not qualify if:

  • patients with stromal keratitis patients with corneal opacity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag University

Sohag, 82524, Egypt

RECRUITING

MeSH Terms

Conditions

Corneal Ulcer

Interventions

AcyclovirTobramycinFluorometholoneHyaluronic Acid

Condition Hierarchy (Ancestors)

Eye InfectionsInfectionsKeratitisCorneal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

GuanineHypoxanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsNebramycinKanamycinAminoglycosidesGlycosidesCarbohydratesPregnadienediolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedGlycosaminoglycansPolysaccharides

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

March 26, 2022

First Posted

April 6, 2022

Study Start

March 18, 2022

Primary Completion

June 28, 2022

Study Completion

July 20, 2022

Last Updated

April 6, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations