The A.R.R.E.S.T.® Contact Lens Study (NCT06878118) | Clinical Trial Compass
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 range
7 Years – 15 Years
Sex
ALL
See this in plain English?
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Axial Length
Timeframe: Baseline, then1 month, 3 months, 6 months, 9 months, and 12 months after baseline
2
Cycloplegic spherical equivalent autorefraction
Timeframe: Baseline, then 6 months, and 12 months after baseline