Study of Blinking as a Function of Tear Film Quality (WINK)

Etude Des Clignements en Fonction de la Qualité du Film Lacrymal

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

Study Overview

• Status: Not yet recruiting
• Conditions: Dry Eye
• Intervention / Treatment: Other: Blink behaviour

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sarah Marié, MSc; Phone Number: +33177749169; Email: mariesa@essilor.fr

Study Locations

• France
  • Paris, France, 94220
    • EssilorLuxottica - Neuroscience & Medical Research center
    • Contact: Sarah Marié, MSc; Phone Number: +33177749169; Email: mariesa@essilor.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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)
• Participants currently in an exclusion period from another study
• Participants deemed unfit to participate by the investigator for any reason that may affect subject safety or study integrity All categories of individuals particularly protected under French law are excluded from this research (Articles L1121-5 to L1121-9 of the French Public Health Code).
• Use of eye drops or ophthalmic solutions within the last 2 hours
• Wearing contact lenses within the last 48 hours
• Reported history of severe ocular pathology such as glaucoma, retinitis pigmentosa, diabetic retinopathy, macular involvement, resulting in visual field loss or acuity loss (especially aphakia), except for dry eye (which is not an exclusion criterion)
• Reported history of eye surgery or trauma to the eye or its adnexa excepted refractive surgery and cataract surgery
• Reported history of eyelid abnormalities (ptosis)
• Reported history of neurological deficits, including epilepsy or sensory-motor coordination disorders, vestibular or cerebellar pathology (e.g., balance disorders, nystagmus, Parkinson's disease)
• Reported history of musculoskeletal disorders preventing maintenance of a fixed head position

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single arm	Other: Blink behaviour; Single intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 .	Day one

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 .		Day one
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 .		Day one
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)	Day one
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 (%)	Day one

Collaborators and Investigators

• Sponsor: Essilor International

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: March 17, 2026
• First Submitted That Met QC Criteria: March 23, 2026
• First Posted (Actual): March 30, 2026

Study Record Updates

• Last Update Posted (Actual): March 30, 2026
• Last Update Submitted That Met QC Criteria: March 23, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: dry eye
• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Dry Eye Syndromes
• Other Study ID Numbers: WS10489; 2025-A02676-43 (Other Identifier: ANSM RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No