Myopia, ProgressiveNCT05331378
Clinical Evaluation of a Myopia Control Lens in Slowing Myopia Progression
A study testing Single vision lenses in people with Myopia, Progressive and Myopia, run by Essilor International at 1 site in Singapore.
Trial summary
This is a monocenter, randomized, controlled, parallel-group, double-masked clinical trial to evaluate the effectiveness of test lens in slowing myopia progression with respect to axial length elongation at baseline compared to a single vision spectacle lens (control). Read more about this study
- Who is it for?
- Ages 8 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia, Progressive, Myopia
- What is being tested?
- Single vision lenses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSingapore
- Study dates
- 25 Apr 2022to Oct 2025
- Phase
- Interventional
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 8 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Volunteer subject and guardian, fluent English spoken, willing to follow protocol and able to read, comprehend and sign the informed consent \& assent form.
- Equal to or greater than 8 years and not older than 13 years at time of informed consent and assent.
- Spherical equivalent refractive error (SER) by manifest refraction between -0.75 and -4.75 D in each eye.
- Astigmatism, if present, of not more than 1.50 D.
- Difference in SER between the two eyes (Anisometropia) by manifest refraction not more than 1.00 D.
- Best corrected visual acuity in each eye equal to or better than +0.10 logMAR (≥ 20/25 as Snellen)
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- Be in good general health based on his/her and parent's/guardian's knowledge. Absence of ocular disease with full ophthalmic examination. Without any ocular or systemic condition known to affect refractive status.
- History of myopia control intervention
- Absence of strabismus by cover test at near or distance wearing correction.
- Absence of amblyopia
- Without ocular or systemic medications which, in the investigator's opinion, may significantly affect pupil size, accommodation or refractive state.
Who cannot join
- Vulnerability of subject
- Participation in any clinical study within 30 days of the Baseline visit.
- Sibling of existing participant of this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-masked, Randomized, 2-armed Comparative Study of a Myopia Control Lens (Test Lens) Versus Single Vision Lens (Control Lens).
This is a monocenter, randomized, controlled, parallel-group, double-masked clinical trial to evaluate the effectiveness of test lens in slowing myopia progression with respect to axial length elongation at baseline compared to a single vision spectacle lens (control). A total of 80 children will be recruited where 40 subjects will be allocated either to wear test lenses (group 1) or control lenses (group 2) for 1 year through randomization.
Read the detailed description
As myopia is a growing worldwide problem, it is important to better understand the range of possible treatments to slow the progression of myopia. Spectacle lenses with aspherical lenslets were shown to be effective in reducing myopia progression and axial length elongation in children in the previous clinical trial. A dose-dependent effect was demonstrated, with higher lenslet asphericity having greater myopia control efficacy.
This double masked parallel group study will test the safety and effectiveness of a test lens designed to modify the area and amount of myopic defocus on the retina without compromising vision. The study population includes children in Singapore aged 8 to 13 years (80 subjects) at the time of commencing treatment. As age of myopia onset is known to be an important factor in rate of myopia progression, subject age at the time of enrollment will be used to balance randomization. Axial length and spherical equivalent refraction will be the primary measure for myopia progression. Visual acuity will also be compared between test lenses and control lenses to determine the quality of vision using test lenses.
- Conditions
- Myopia, Progressive, Myopia
- Being tested
- Test myopia control lenses, Single vision lenses
- Keywords
- refractive error, eye disease, short-sightedness, children myopia, myopia progression
- Medical subject headings
- Myopia, Degenerative, Myopia, Refractive Errors, Eye Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test myopia control lensesDevice
A myopia control spectacle lenses (test lenses) will be given to 1 arm to wear for 12 months.
Single vision lensesDevice
A single vision spectacle lenses (control lenses) will be given to 1 arm to wear for 12 months.
| Study group | Role | What they receive |
|---|---|---|
| Test myopia control lenses | Experimental | A myopia control spectacle lenses (test lenses) will be given to 1 arm to wear for 12 months. Receives: Device: Test myopia control lenses |
| Single vision lenses | Other | A single vision spectacle lenses (control lenses) will be given to 1 arm to wear for 12 months. Receives: Device: Single vision lenses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Axial Length
Change in ocular axial length (mm) measured using Lenstar Optical Biometer.
Measured: 12 months
Secondary outcomes (3)
Spherical Equivalent Refraction
Change in spherical equivalent refraction (Dioptres) through manifest subjective refraction.
Measured: 6 months and 12 months
Axial Length
Change in ocular axial length (mm) measured using Lenstar Optical Biometer.
Measured: 6 months
Carry-over Effect
Change in ocular axial length (mm) measured using Lenstar Optical Biometer after switching to STELLEST™ lenses
Measured: 18 months and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2022
- Study start25 Apr 2022
- Primary completion29 Oct 2024
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myopia, ProgressiveStudies of the same condition, open and under way.
- 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
- Model description
- This is a randomized, controlled, 2-armed, double-masked, monocenter, clinical trial, which consists of 6 visits across 1 year. The test myopia control lens will be compared with a single vision control lens in evaluating study objectives. After obtaining informed consent and assent, a comprehensive eye examination for screening will be done among approximately 80 myopic children between the age of 8-13 years old for eligibility. After randomization, the subjects will be back for dispensing of study spectacles and for baseline visit, where assessment of study spectacles, biometry, and instructions to use study spectacles were done. A follow up visit will be conducted in 3, 6 and 12 months time, in which the latter visit will also be the end of visit. All of which are non-contact and non-invasive to the eyes.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Essilor International
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrew Tan, Principal investigator, Essilor R&D Centre Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05331378
- Sponsor's protocol ID
- WS10258
- Status last verified
- Aug 2024
- First submitted
- 8 Apr 2022
- Last updated
- 7 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bao J, Yang A, Huang Y, Li X, Pan Y, Ding C, Lim EW, Zheng J, Spiegel DP, Drobe B, Lu F, Chen H. One-year myopia control efficacy of spectacle lenses with aspherical lenslets. Br J Ophthalmol. 2022 Aug;106(8):1171-1176. doi: 10.1136/bjophthalmol-2020-318367. Epub 2021 Apr 2.
PubMed 33811039