A.R.R.E.S.T.® contact lenses to slow myopia in children

Prospective, Controlled, Randomised, Contralateral Wear, Dispensing Trial to Assess the Efficacy of Contact Lenses Using A.R.R.E.S.T.® Technology

This test will see if A.R.R.E.S.T.® contact lenses can slow eye growth and worsening nearsightedness in children aged 7–15 compared with regular single‑vision contact lenses.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 7 Years to 15 Years
• Sex: All
• Sponsor: nthalmic Pty Ltd (Research network)
• Locations: 2 sites (Wenzhou, Zhejiang and 1 other locations)
• Trial ID: NCT06878118 on ClinicalTrials.gov

What this trial studies

Children aged 7–15 with myopia are randomly assigned to wear either the A.R.R.E.S.T.® contact lens or a standard single‑vision contact lens and will be followed for about 12 months with seven clinic visits. The trial measures change in axial length and change in spherical equivalent cycloplegic autorefraction from baseline to compare rates of myopia progression between groups. Participants must wear lenses daily (remove at night) with a minimum wearing schedule and complete standard, noninvasive eye tests at each visit. The overall program, including follow-up, is expected to take about 18 months with each participant enrolled for approximately 12 months.

Who should consider this trial

Good fit: Ideal candidates are children aged 7–15 with myopia who can wear daily contact lenses as directed, attend scheduled clinic visits, and whose parent/guardian can provide informed consent.

Not a fit: Children outside the 7–15 age range, those unable or unwilling to follow the daily‑wear schedule or visit requirements, or those with ocular conditions that affect measurements are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, these lenses could slow axial elongation and reduce the progression of childhood myopia, lowering the risk of high myopia later in life.

How similar studies have performed: Other contact lens approaches (for example multifocal soft lenses and orthokeratology) have shown the ability to slow axial elongation, but the A.R.R.E.S.T.® signal technology is a novel approach that has less published clinical evidence to date.

Eligibility criteria

Inclusion Criteria

* Be between 7 to 15 years old inclusive at time of enrolment.
* Have:

  * Read the Informed Assent.
  * Been explained the Informed Assent.
  * Indicated an understanding of the Informed Assent.
  * Signed the Informed Assent.
* Have their parent / legal guardian.

  * Read the Informed Consent.
  * Been explained the Informed Consent.
  * Indicated an understanding of the Informed Consent.
  * Signed the Informed Consent.
* Along with their parent/legal guardian, be capable of comprehending the nature of the study and be willing to adhere to the study requirements.
* Along with their parent/legal guardian, agree to maintain the visit and prescribed wearing schedule.
* Agree to wear the study contact lenses for a minimum of 5 days/week, 6 hours/day on days lenses are worn but not \> 16 hours per day, and to remove lenses at night (i.e., daily wear only with no contact lens wear during sleep), for the duration of the study and to inform the investigator if their schedule is interrupted. Wearing time can be modified by the investigator for health reasons.
* Be in good general health, based on parent's/legal guardian's knowledge.
* Have best-corrected high contrast visual acuity of 0.10 logMAR (Snellen: 20/25, 6/7.6; Decimal: 0.80) or better in each eye.
* Meet the following criteria determined by cycloplegic autorefraction at Baseline:

  * -4.00 D ≤ spherical equivalent ≤ 0.75 D
  * -1.00 DC ≤ astigmatic component ≤ 0 DC
* Participants who fail astigmatism criterion with autorefraction pass astigmatism criterion if ≥ 0.75 D is measured with subjective refraction.

  * \|Spherical equivalent anisometropia\| ≤ 1.00 D.

Exclusion Criteria

* Participant in another study within 30 days prior to this study.
* Current or prior use of interventions intended for myopia control, including but not limited to:
* Optical devices:

  * Bifocal / multifocal spectacles.
  * Bifocal / multifocal contact lenses.
  * Orthokeratology.
* Pharmacological agents:

  * Atropine with a concentration \> 0.01%.
  * Participants who have previously used 0.01% atropine are eligible for this study provided they agree not to use 0.01% atropine for at least 30 days before baseline and at any time during the study.
  * Pirenzepine.
* Participant born earlier than 30 weeks or weighed \< 1500 g at birth.

  o A verbal report from the participant's parent / legal guardian is sufficient.
* Habitual use of a systemic or topical medication that may alter normal ocular findings / is known to affect a participant's ocular health / physiology either in an adverse or beneficial manner at enrolment and / or during the clinical trial.
* A known allergy to sodium fluorescein, benoxinate, proparacaine, tropicamide, or cyclopentolate.
* A known corneal hypoesthesia (reduced corneal sensitivity), corneal ulcer, corneal infiltrates, ocular viral or fungal infections, or any other recurrent ocular infections.
* Strabismus as determined by cover test at distance (≥ 3 m) or near (40 cm) while wearing distance correction under non-cycloplegic conditions.
* Known ocular or systemic disease, such as but not limited to:

  * Diabetes.
  * Graves' disease.
  * Glaucoma.
  * Uveitis.
  * Scleritis.
  * Auto immune diseases such as ankylosing spondylitis, multiple sclerosis, Sjogrens syndrome, and systemic lupus erythematosus.
  * Any ocular, systemic, or neuro-developmental conditions that could influence refractive development, such as but not limited to:
  * Persistent pupillary membrane.
  * Vitreous haemorrhage.
  * Cataract.
  * Central corneal scarring.
  * Eyelid haemangiomas.
  * Marfan's syndrome.
  * Down's syndrome.
  * Ehler's-Danlos syndrome.
  * Stickler's syndrome.
  * Ocular albinism.
  * Retinopathy of prematurity.
  * Keratoconus or irregular cornea.
* Biomicroscopic that contraindicate contact lens, such as but not limited to:

  * Neovascularisation or ghost vessels ≥ 1.5 mm in from limbus.
  * Any active anterior segment disease that contraindicates safe contact lens wear.
  * Clinically significant giant papillary conjunctivitis.
  * Clinically significant abnormalities of the anterior segment, lids, conjunctiva, sclera, or associated structures.
  * Allergic or seasonal conjunctivitis if the investigator believes it could significantly interfere with maintaining a specified wearing schedule.
* The investigator may, at their discretion, exclude anyone who they believe may not be able to fulfil the clinical trial requirements or it is believed to be in the participant's best interests.

Where this trial is running

Wenzhou, Zhejiang and 1 other locations

• Wenzhou Medical University — Wenzhou, Zhejiang, China (Recruiting)
• Optometry Clinic, Faculty of Health Science, Universiti Kebangsaan Malaysia — Kuala Lumpur, Malaysia (Recruiting)

Study contacts

• Study coordinator: Daniel Tilia, PhD

Conditions Myopia; Myopia Progression; axial length