GlarePREVISNCT06701981
Study on the Effect of Filters on Discomfort Glare on Healthy Adults
A study testing Filter comparison in people with Glare, run by Essilor International at 1 site in France.
Trial summary
The goal of this clinical trial is to evaluate the glare protection provided by two filters compared to no filter. Using the Lumiz 100™ device (a headset with gradually increasing light), participants will measure their discomfort thresholds under three different conditions (one per filter). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Glare
- What is being tested?
- Filter comparison
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 2 Dec 2024to 31 Mar 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- A willing person, fluent in French, inclined to follow protocol, capable of reading and understanding the information form, and able to give their free and informed consent.
- Beneficiary of the French Social Security system
- Aged 18 to 65 years
- No or moderate ocular correction (Spherical prescription for distance vision: in the range [-8.00 to +6.00 D]* (negative cylinder) for each eye; Cylindrical prescription for distance vision: in the range [0 to -4.00 D] for each eye; Anisometropia ≤ 2.00 D on the equivalent sphere)
- Correct vision with prescription glasses (Corrected visual acuity +0.10 logMAR or better (distance vision / high contrast / photopic luminance)
- Regular user of sunglasses at least in bright light conditions
Who cannot join
- Age < 18 years (i.e., no minors in accordance with Article L1121-7 of the Public Health Code of "Code de Santé Publique")
- Pregnant, parturient, or breastfeeding women (Article L1121-5 of the Public Health Code of "Code de Santé Publique")
- Persons deprived of liberty by judicial or administrative decision and persons hospitalized without consent under Articles L. 3212-1 and L. 3213-1 who do not fall under the provisions of Article L. 1121-8, and persons admitted to a health or social institution for purposes other than research
- Adults incapable or unable to express their consent (Article L1121-8 of the Public Health Code of "Code de Santé Publique")
- Participant in the exclusion period of another biomedical research study
- Participant who cannot be contacted in case of emergency
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- All categories of persons particularly protected under French law are excluded from this research (Articles L1121-5 to L1121-9 of the Public Health Code)
- Employees at the Institut des Sciences de la Vision or EssilorLuxottica
- Ocular pathology that may affect vision (e.g., glaucoma involving visual field loss, maculopathy involving visual acuity loss, or retinitis pigmentosa causing significant discomfort in poorly or overly lit environments)
- Neurological deficit, including a history of epileptic pathology or regular or severe migraines
- Ocular surgery affecting vision (e.g., refractive surgery, cataract surgery, or iridectomy)
- Ocular or head trauma
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Institut des Sciences de la Vision
Saint-Etienne, France, 42100
Aurore Munier, Doctor of Optometry, + 33 (0) 4 77 95 31 70, a.munier@isvision.fr
Aurore Munier, Doctor of optometry
About this study
Official title: Etude De L'Effet De Filtres Sur L'Eblouissement D'Inconfort
The goal of this clinical trial is to evaluate the glare protection provided by two filters compared to no filter. Using the Lumiz 100™ device (a headset with gradually increasing light), participants will measure their discomfort thresholds under three different conditions (one per filter). Each measurement will be repeated three times. The study requires a single visit of 2 hours for each participant. Glare protection will be quantified by comparing discomfort thresholds across the no-filter condition and the two studied filters.
- Conditions
- Glare
- Being tested
- Filter comparison
- Keywords
- glare, filter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Filter comparisonOther
Three filters will be compared on light discomfort thresholds using the Lumiz 100™ device
| Study group | Role | What they receive |
|---|---|---|
| Glare discomfort measures with filters | Experimental | Not described Receives: Other: Filter comparison |
What is being measured
The primary outcome is the main question the study is designed to answer.
Light discomfort thresholds
Amount of light (in lux) that produce a defined discomfort level (just perceptible or really disturbing)
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2024
- Study start2 Dec 2024 (estimated)
- Primary completion28 Mar 2025 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlareStudies of the same condition, open and under way.
- More trials run by Essilor InternationalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Essilor International
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pascale Lacan, Phd, Study director, Essilor International
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06701981
- Sponsor's protocol ID
- WS10399
- Other IDs
- 2024-A00934-43
- Acronym
- PREVIS
- Status last verified
- Nov 2024
- First submitted
- 20 Nov 2024
- Last updated
- 22 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Etude De L'Effet De Filtres Sur L'Eblouissement D'Inconfort
- ClinicalTrials.gov ID
- NCT06701981
- Acronym / sponsor ID
- PREVIS / WS10399
- Conditions
- Glare
- Keywords
- glare, filter
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Essilor InternationalIndustry (pharma, biotech, devices)
- Study start
- 2 Dec 2024 (estimated)
- Primary completion
- 28 Mar 2025 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 22 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to evaluate the glare protection provided by two filters compared to no filter. Using the Lumiz 100™ device (a headset with gradually increasing light), participants will measure their discomfort thresholds under three different conditions (one per filter). Each measurement will be repeated three times. The study requires a single visit of 2 hours for each participant. Glare protection will be quantified by comparing discomfort thresholds across the no-filter condition and the two studied filters.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Glare discomfort measures with filters | Experimental | Other: Filter comparison |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- A willing person, fluent in French, inclined to follow protocol, capable of reading and understanding the information form, and able to give their free and informed consent.
- Beneficiary of the French Social Security system
- Aged 18 to 65 years
- No or moderate ocular correction (Spherical prescription for distance vision: in the range [-8.00 to +6.00 D]* (negative cylinder) for each eye; Cylindrical prescription for distance vision: in the range [0 to -4.00 D] for each eye; Anisometropia ≤ 2.00 D on the equivalent sphere)
- Correct vision with prescription glasses (Corrected visual acuity +0.10 logMAR or better (distance vision / high contrast / photopic luminance)
Key exclusion criteria (12 listed)
- Age < 18 years (i.e., no minors in accordance with Article L1121-7 of the Public Health Code of "Code de Santé Publique")
- Pregnant, parturient, or breastfeeding women (Article L1121-5 of the Public Health Code of "Code de Santé Publique")
- Persons deprived of liberty by judicial or administrative decision and persons hospitalized without consent under Articles L. 3212-1 and L. 3213-1 who do not fall under the provisions of Article L. 1121-8, and persons admitted to a health or social institution for purposes other than research
- Adults incapable or unable to express their consent (Article L1121-8 of the Public Health Code of "Code de Santé Publique")
- Participant in the exclusion period of another biomedical research study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Filter comparisonThree filters will be compared on light discomfort thresholds using the Lumiz 100™ device | Other | Glare discomfort measures with filters |
Primary outcome
Light discomfort thresholds
Time frame: 2 hours
Amount of light (in lux) that produce a defined discomfort level (just perceptible or really disturbing)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2024.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pascale Lacan, Phd study director
Essilor International
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Filter comparison in people with Glare, run by Essilor International at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pascale Lacan, PhD (+33155964816, lacanp@essilor.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Light discomfort thresholds (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2024.