NCT02045082

Brief Summary

The purpose of this study is to compare a corneal sampling realized by a flocked swab (flocked swab regular 519CS01) with a sampling by traditional fiber swab (Copan regular swab 164KS01 in polyester). Their impact on the sensibility of the viral culture in the Herpes simplex epithelial keratitis will be the primary objective of this study.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
146

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Oct 2013

Geographic Reach
1 country

1 active site

Status
terminated

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, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 21, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 24, 2014

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

February 26, 2016

Status Verified

January 1, 2016

Enrollment Period

2 years

First QC Date

January 21, 2014

Last Update Submit

February 25, 2016

Conditions

Herpes Simplex Keratitis

Keywords

Flocked swabTraditional fiber swabHerpes simplex epithelial keratitisQuantitative PCR

Outcome Measures

Primary Outcomes (1)

  • Result of the culture

    The result can be Positive or negative for Herpes simplex virus (HSV). Even if the result will be available in less than 1 week by the clinician after the culture, the research team will collect the data 1 month in average after the initial visit.

    1 month after the initial visit

Secondary Outcomes (2)

  • Time before positivity of the culture

    1 month after the initial visit

  • Viral load concentration

    1 month after the initial visit

Study Arms (2)

Flocked swab (Copan 519CS01)

EXPERIMENTAL

Sampling of the cornea by the flocked swab

Procedure: Corneal sampling

Traditionnal fiber swab (Copan 164KS01)

EXPERIMENTAL

Sampling of the cornea by the traditional finer swab

Procedure: Corneal sampling

Interventions

Corneal samplingPROCEDURE

Slit lamp corneal sampling with a Swab

Flocked swab (Copan 519CS01)Traditionnal fiber swab (Copan 164KS01)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Slit lamp signs at the initial examination that are compatible with an Herpes simplex epithelial keratitis (Herpes simplex dendrite, herpes simplex geographic ulcer)

You may not qualify if:

  • Topical or systemic antiviral Therapy during the last 14 days Patient with Herpes simplex stromal keratitis without epithelial involvement Herpetic lesion outside the cornea

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre universitaire d'ophtalmologie, Hôpital du Saint-Sacrement, CHU de Québec

Québec, Quebec, G1S 4L8, Canada

Location

MeSH Terms

Conditions

Keratitis, Herpetic

Condition Hierarchy (Ancestors)

Eye Infections, ViralEye InfectionsInfectionsHerpes SimplexHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesKeratitisCorneal DiseasesEye Diseases

Study Officials

  • Patricia-Ann Laughrea, MD, CRMC(C)

    Centre de recherche du CHU de Québec; Université Laval

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2014

First Posted

January 24, 2014

Study Start

October 1, 2013

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

February 26, 2016

Record last verified: 2016-01

Locations

CA(1)