ClinicalTrials.gg
RecruitingNCT07462897VERCORSUpdated Apr 23, 2026

Evaluation of the Effectiveness of a New Generation of Myopia Control Lens on the Progression of Myopia in Children Aged 6 to 14 Years

An interventional study of MCL1 and MCL2 in Myopia Progression, sponsored by Essilor International. Recruiting at 1 site in France. Open to participants aged 6 Years to 14 Years. Per ClinicalTrials.gov, last updated 2026-04-23.

Sponsored by Essilor International · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Mar 2026; still recruiting 7 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
76
Allocation
Randomized
Ages
6 Years to 14 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 28 studies in Myopia by EssilorLuxottica — 14 open to participants now, 19 under way, none of them phase 3. Myopia · EssilorLuxottica.

Planned enrollment
13th of 28
76 · median 52
Started
2026
with 8 others
No phase
28 of 28
14 open now
Primary completion
2028-04
later than 18 of 18 live
Registered
21st of 28
by date

Among the 28 studies in Myopia by EssilorLuxottica, this one is the 13th largest by planned enrollment, is one of 9 that started in 2026, is one of 28 with no phase, reaches primary completion later than 18 of the 18 other live ones, and was the 21st registered.

Myopia

1,159 studies on the registry are indexed under Myopia; 225 are open to participants now.

Browse Myopia studies →

Open to participants now

14 of the 28 studies in Myopia by EssilorLuxottica are open now, in 5 countries. Recruiting first, the newest first:

8 more — sign in →

By country, each count listing its studies:

All 14 open studies →

Who these studies take

Of the 122 Myopia studies recruiting now, 19 (16%) set no upper age limit and 102 (84%) stop at 75 or younger; 86 take children under 18; 53 take healthy volunteers.

This study: 6 Years to 14 Years · all sexes · no healthy volunteers.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 28 studies in Myopia by EssilorLuxottica, or all of them as a file.
02

Study summary

The goal of this clinical investigation is to learn how much a new generation of myopia control lens (MCL1 - Myopia Control Lens 1) is helpful in reducing myopia progression in children from 6 to 14 yo. The main questions it aims to answer is: How much this new generation of lens, called MCL1, slows down the growth of the eye? Researchers will compare MCL1 to a former generation of myopia control lens (i.e. MCL2) but with better vision quality.

Participants will:

  • Wear MCL1 on right eye and MCL2 on left eye for 6 months and MCL2 on rigth eye and MCL1 on left eye for the next 6 months;
  • Visit the hospital at 6 and 12 months for tests;
  • Answer weekly questionnaires on compliance wearing glasses, quality of vision and out-of-school activities.
Read the detailed description

Myopia is a global public health issue that could affect nearly 5 billion people by 2050. It progresses rapidly in children, increasing the risk of severe ocular diseases. Several solutions exist to slow its progression, including ophthalmic lenses, which are effective and free of side effects. Essilor® Stellest® lenses, incorporating H.A.L.T. technology with aspherical lenslets, slow axial eye elongation with an efficacy comparable to high-dose atropine.

A new version of this product provides an enhanced myopia-control signal thanks to increased optical parameters of the lenslets. A recent study has demonstrated its superior effectiveness in Asian children aged 6 to 10. The present study aims to assess its performance in European children, compared with another myopia control lens, which delivers the same myopia-control signal as the original Stellest® lens but with better visual quality.

The study will take into account interindividual variability in efficacy, particularly with respect to age-a key factor in myopia progression (which is high between ages 6 and 8). Three age groups will be analyzed (6-8, 9-11, and 12-14 years). A secondary objective is to explore the impact of individual ocular parameters on lens effectiveness.

03

Conditions studied

  • Myopia Progression

Browse trials for

04

Who can participate

Ages eligible
6 Years to 14 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Refractive error in spherical equivalent (SE) ≤ -0.5 D and ≥ -4.5 D on each eye (autorefraction under cycloplegia)
  • Astigmatism ≤ 2.00 D for each eye
  • Anisometropia (difference in SE between the 2 eyes) ≤ 1.00 D
  • Corrected maximum distance visual acuity in each eye≥ 8/10 (equivalent to +0.1 LogMAR)
  • Written consent of the 2 holders of parental authority (or only one in the case of exclusive parental authority) and agreement of the participant

Exclusion criteria

Exclusion Criteria:

  • Past or current use of any type of myopic control solution (braking lenses, atropine, orthokeratology, multifocal contact lenses, etc
  • Strabismus (in the test of masking near or far with the best correction)
  • Amblyopia
  • Any ocular or systemic condition known to affect refractive status (e.g., keratoconus, diabetes, Down syndrome, etc.)
  • Presence of trauma in at least one eye - Presence of inflammatory pathologies in at least one eye
  • History of intraocular surgery (cataracts, filtering surgery, intravitreal surgery) in at least one eye
  • Past or current use of growth hormones
  • Use of ocular or systemic drugs that, in the opinion of the investigator, may significantly affect pupil size, accommodation, or refractive status.
  • Wearing contact lenses
  • Allergy or intolerance to cycloplegic eye drops (cyclopentolate 0.5%)
  • Known allergy or intolerance to eyeglass frame materials
  • Children with specific visual disorders requiring personalized treatments other than conventional corrective lenses.
  • Intolerance to conventional optical corrections
  • Lack of cooperation in wearing corrective lenses
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
76 participants (estimated)

Study arms

  • Experimental
    OD: MCL 1; OS: MCL 2

    Each participant wears the study eyeglasses containing both Myopia Control Lens 1 (MCL 1) and Myopia Control Lens 2 (MCL 2) design, with one type of lens in each eye throughout the study period. For Arm 1, MCL 1 will be worn in the right eye, and MCL 2 in the left eye for a period of 6 months.

    Device: MCL1 · Device: MCL2

  • Experimental
    OD: MCL 2; OS: MCL 1

    Each participant wears the study eyeglasses containing both Myopia Control Lens 1 (MCL 1) and Myopia Control Lens 2 (MCL 2) design, with one type of lens in each eye throughout the study period. For Arm 2, MCL 2 will be worn in the right eye, and MCL 1 in the left eye for a period of 6 months.

    Device: MCL1 · Device: MCL2

Interventions

  • DeviceMCL1

    Myopia Control Lens 1 (MCL 1) is an ophthalmic lens intended to slow down eye growth in children.

  • DeviceMCL2

    Myopia Control Lens 2 (MCL 2) is an ophthalmic lens intended to slow down eye growth in children.

06

What researchers measure

Primary outcomes

  1. Change from baseline in axial length

    Time frame: 6-month

Secondary outcomes

  1. Change from baseline in cycloplegic spherical equivalent

    Time frame: 6-month

  2. Effect of optical parameters, assessed at baseline, on myopia control efficacy of MCL1 and MCL2 at 6-month.

    Correlation between amount of ocular aberrations (Root Mean Square of global High Order Aberrations) at baseline and the change of eye length induced by wearing MCL1 vs MCL2 at 6-month.

    Time frame: 6-month

  3. Effect of self-reported exposure time to natural light on myopia control efficacy of MCL1 and MCL2 at 6-month

    Correlation between self-reported weekly hours of exposure to natural outdoor light, assessed with questionnaires each week and averaged at 6-month, and the change of axial length induced by wearing MCL1 vs MCL2 at 6-month.

    Time frame: 6-month

07

Study locations

1 of 1 sites recruiting
  • Département d'Ophtalmologie, Hôpital Fondation Adolphe de Rothschild
    Paris, 75019, France
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2026 (actual). Primary completion is estimated for Apr 2028, 25 months after the start.

Of 234 industry-sponsored interventional studies with no phase under Myopia, half reached primary completion within 6 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 24. This study's planned 25 months is above that.

Counting every sponsor, half of 434 studies reached it within 14 months; a quarter within 3 and three quarters within 34.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 27, 2026
First posted
Mar 10, 2026
StartActual
Mar 18, 2026
Primary completionEst.
Apr 2028
CompletionEst.
May 2028
Last update
Apr 23, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07462897
Responsible party
Sponsor
First posted
Mar 10, 2026
Start date
Mar 18, 2026
Primary completion
Apr 2028 (estimated)
Completion
May 2028 (estimated)
Last update
Apr 23, 2026

Study contacts

Thibaut Chapron, MD
Contact
tchapron@for.paris
00331 48 03 65 56

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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