RecruitingNot Applicable

The A.R.R.E.S.T.® Contact Lens Study

China, Malaysia80 participantsStarted 2025-07-06

Plain-language summary

The goal of this clinical trial is to learn if contact lenses using Active Reconfiguration in Retinal Encoding of Spatio-Temporal (A.R.R.E.S.T.®) signal technology works to slow down the rate of myopia progression compared to single vision contact lenses in myopic children. The main questions it aims to answer are: Do contact lenses using A.R.R.E.S.T.® technology slow down the rate of axial length growth? Do contact lenses using A.R.R.E.S.T.® technology slow down the rate of increase in myopic refractive error? Researchers will compare contact lenses using A.R.R.E.S.T.® technology to a single vision contact lens. Participants will: Be randomly allocated to wear either contact lenses using A.R.R.E.S.T.® technology or single vision contact lenses. Visit the clinic on seven occasions over a 12 month period.

Who can participate

Age range7 Years – 15 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 astigmatis…

What they're measuring

Axial Length

Timeframe: Baseline, then1 month, 3 months, 6 months, 9 months, and 12 months after baseline

Cycloplegic spherical equivalent autorefraction

Timeframe: Baseline, then 6 months, and 12 months after baseline

Trial details

NCT IDNCT06878118

Sponsornthalmic Pty Ltd

Sponsor typeNETWORK

Study typeINTERVENTIONAL

Primary completion2026-05-01

Contact for this trial

Daniel Tilia, PhD

61290377700 emu@nthalmic.com