MyopiaFIN-3102NCT07668102
Visual Performance of Highly Aspherical Lenslet Spectacles in Children (Ancillary to WS10246)
A study testing HAL spectacle lens and Single Vision spectacle lens in people with Myopia, run by Essilor International at 7 sites in United States.
Trial summary
To evaluate the visual performance of (high and low contrast distance visual acuity, reading speed, near visual acuity, and near contrast sensitivity) of HAL spectacle lenses (habitual correction) in comparison with single vision control lenses. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Myopia
- What is being tested?
- HAL spectacle lens and Single Vision spectacle lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 7 sitesUnited States
- Study dates
- 22 May 2024to 20 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Existing subjects from Essilor R\&D Study WS10246 clinical study.
- Ability to comply with study procedures.
- Informed consent of parent/guardian and assent of subject.
Who cannot join
- Current ocular infection, inflammation, or irritation likely to affect vision.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
New England College of Optometry
Boston, Massachusetts, 02115
Illinois College of Optometry
Chicago, Illinois, 60616
Sabal Eye Care
Longwood, Florida, 32779
SUNY College of Optometry
New York, New York, 10036
Kannarr Eye Care
Pittsburg, Kansas, 66762
Scripps Poway Optometry
San Diego, California, 92131
Sacco Eye Group
Vestal, New York, 13850
About this study
Official title: Clinical Evaluation of Vision Performance of the FIN C2 Lens
To evaluate the visual performance of (high and low contrast distance visual acuity, reading speed, near visual acuity, and near contrast sensitivity) of HAL spectacle lenses (habitual correction) in comparison with single vision control lenses.
- Conditions
- Myopia
- Being tested
- HAL spectacle lens, Single Vision spectacle lens
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HAL spectacle lensDevice
HAL spectacle lens for myopia control
Single Vision spectacle lensDevice
Single vision spectacle lens for myopia and astigmatism correction
| Study group | Role | What they receive |
|---|---|---|
| HAL spectacle lens | Experimental | HAL spectacle lens using a innovative spectacle lens to control myopia progression Receives: Device: HAL spectacle lens |
| Single vision spectacle lens | Placebo comparator | Single vision spectacle lens for myopia and astigmatism correction Receives: Device: Single Vision spectacle lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reading Speed
Reading speed (mean words per minute) collected using the Wolffsohn Research iPad OptomCentral App
Measured: Between Year 1 and Year 2 of the WS10246 study, representing an average timeframe of 1.5 years into the parent study.
Secondary outcomes (2)
Binocular distance high contrast visual acuity (VA) through the lens periphery
Measured to the nearest letter using a standard ETDRS chart at 4 meters.
Measured: Between Year 1 and Year 2 of the WS10246 study, representing an average timeframe of 1.5 years into the parent study.
Binocular photopic near contrast sensitivity function (CSF)
Evaluated at 40 cm using the iPad OptomCentral App across various spatial frequencies to calculate the Area Under the Log Contrast Sensitivity Function (AULCSF).
Measured: Between Year 1 and Year 2 of the WS10246 study, representing an average timeframe of 1.5 years into the parent study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2026
- Study start22 May 2024
- Primary completion20 Sep 2024
- Study completion20 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyopiaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Essilor International
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Visioncare Research Ltd.
- Responsible party
- Sponsor
- Investigators
- Jason Shen, PhD, Study director, Essilor International, Affiliation of EssilorLuxottica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07668102
- Sponsor's protocol ID
- WS10353
- Acronym
- FIN-3102
- Status last verified
- Jun 2026
- First submitted
- 15 Jun 2026
- Last updated
- 25 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Vision Performance of the FIN C2 Lens
- ClinicalTrials.gov ID
- NCT07668102
- Acronym / sponsor ID
- FIN-3102 / WS10353
- Conditions
- Myopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Essilor InternationalIndustry (pharma, biotech, devices)
- Collaborators
- Visioncare Research Ltd.
- Study start
- 22 May 2024 (actual)
- Primary completion
- 20 Sep 2024 (actual)
- Study completion
- 20 Oct 2024 (actual)
- First posted
- 25 Jun 2026 (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.
To evaluate the visual performance of (high and low contrast distance visual acuity, reading speed, near visual acuity, and near contrast sensitivity) of HAL spectacle lenses (habitual correction) in comparison with single vision control lenses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HAL spectacle lens | Experimental | Device: HAL spectacle lensHAL spectacle lens using a innovative spectacle lens to control myopia progression |
| Single vision spectacle lens | Placebo comparator | Device: Single Vision spectacle lensSingle vision spectacle lens for myopia and astigmatism correction |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Existing subjects from Essilor R\&D Study WS10246 clinical study.
- Ability to comply with study procedures.
- Informed consent of parent/guardian and assent of subject.
Key exclusion criteria (1 listed)
- Current ocular infection, inflammation, or irritation likely to affect vision.
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 |
|---|---|---|
| HAL spectacle lensHAL spectacle lens for myopia control | Device | HAL spectacle lens |
| Single Vision spectacle lensSingle vision spectacle lens for myopia and astigmatism correction | Device | Single vision spectacle lens |
Primary outcome
Reading Speed
Time frame: Between Year 1 and Year 2 of the WS10246 study, representing an average timeframe of 1.5 years into the parent study.
Reading speed (mean words per minute) collected using the Wolffsohn Research iPad OptomCentral App
2 secondary outcomes
Binocular distance high contrast visual acuity (VA) through the lens periphery
Time frame: Between Year 1 and Year 2 of the WS10246 study, representing an average timeframe of 1.5 years into the parent study.
Binocular photopic near contrast sensitivity function (CSF)
Time frame: Between Year 1 and Year 2 of the WS10246 study, representing an average timeframe of 1.5 years into the parent study.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
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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. This study is not recruiting at the moment.
Jason Shen, PhD study director
Essilor International, Affiliation of EssilorLuxottica
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HAL spectacle lens and Single Vision spectacle lens in people with Myopia, run by Essilor International at 7 sites in United States.
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 3 inclusion and 1 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: finished, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reading Speed (time frame: Between Year 1 and Year 2 of the WS10246 study, representing an average timeframe of 1.5 years into the parent study.). 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 25 Jun 2026.