Study of Blinking as a Function of Tear Film Quality
ConditionDry Eye
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorEssilor International
About this trial
The goal of this study is to better understand how eye blinking behavior is linked to the stability of the tear film, in adults aged 18 to 65 years, with or without symptoms of dry eye.
The main questions are:
* Do the results of a New Blink Task reflect tear film stability ? * How are the blink related metrics in relation with each other? Researchers will compare two groups of participants-those without dry eye symptoms and those with dry eye symptoms-to see if blinking measures differ between them and whether these measures relate differently to tear film quality.
Participants will:
* Answer a questionnaire about dry eye symptoms * Have their visual correction measured (if they wear glasses) * Undergo non-invasive assessments of tear film quality using an imaging device * Complete three types of blink tasks, each repeated three times, including measurements of blinking and of tear film stability
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Volunteer, fluent in French, willing to follow the protocol, able to read and understand the information sheet and provide free and informed consent
Covered by a social security
Aged between 18 and 65 years inclusive
Binocular near visual acuity ≤ 0.3 LogMAR (≥ 5/10) (corrective glasses accepted)
Disqualifiers
Employees of Essilor International, Luxottica, or GrandVision and their subsidiaries
Pregnant or breastfeeding women (Article L1121-5)
Individuals deprived of liberty by judicial or administrative decision, or hospitalized without consent under Articles L.3212-1 and L.3213-1, who do not fall under Article L.1121-8, and individuals admitted to a health or social care facility for purposes other than research
Adults unable or incapable of giving informed consent (Article L1121-8)
Trial design
Design model
Single group
Treatments tested in this trial
Blink behaviour
Other interventionSingle intervention
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: Single armExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Evaluates the correlation between the Absolute Maximum Eye Aperture Duration measured in seconds and the non-invasive tear film break-up time measured in seconds measured with device IDRA .
Time frame
Day oneSecondary outcomes
1
Evaluates the correlation between the Absolute Maximum Eye Aperture Duration measured in seconds with parameters of dry eye ( tears meniscus height (mm), bulbar redness grade (from 0 to 4), blink quality (in %)) measured with device IDRA .
Time frame
Day one2
Compares the coefficient of variation of the Absolute Maximum Eye Aperture Duration (in %) with the coefficient of variation of the non-invasive tear film break-up time (in %) measured with device IDRA .
Time frame
Day one3
Evaluate the effects of ocular surface characteristics, demographics, and task acceptability on two primary outcomes via linear regression model
Uses linear regression models to evaluate the effects of ocular surface characteristics (tears meniscus height (mm), bulbar redness grade (from 0 to 4), blink quality (in %) measured with device IDRA , demographics (age and gender), and task acceptability (questionnaire) on two primary outcomes: Absolute Maximum Eye Aperture Duration (seconds) and the non-invasive tear film break-up time (seconds)
Time frame
Day one4
Evaluate the effects of ocular surface characteristics, demographics, and task acceptability on coefficient of variation of two primary outcomes via linear regression model
Uses linear regression models to evaluate the effects of ocular surface characteristics (tears meniscus height (mm), bulbar redness grade (from 0 to 4), blink quality (in %) measured with device IDRA , demographics (age and gender), and task acceptability (questionnaire) on two primary outcomes: Absolute Maximum Eye Aperture Duration (seconds) and the non-invasive tear film break-up time (seconds) on coefficient two primary outcomes: Absolute Maximum Eye Aperture Duration (%) and the non-invasive tear film break-up time (%)
Time frame
Day oneSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: