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MyopiaNCT06878118

The A.R.R.E.S.T.® Contact Lens Study

A study testing Single-vision contact lens and A.R.R.E.S.T.® contact lens in people with Myopia and Myopia Progression, run by nthalmic Pty Ltd at 2 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 7 to 15 years
Conditions the study is for
Myopia, Myopia Progression
What is being tested?
Single-vision contact lens and A.R.R.E.S.T.® contact lens
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
2 sitesin 2 countries
Study dates
6 Jul 2025to 1 Jun 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

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 7 to 15 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

China1 site

  • Wenzhou Medical University

    Wenzhou, Zhejiang, 325000

Other trials in China

Malaysia1 site

  • Optometry Clinic, Faculty of Health Science, Universiti Kebangsaan Malaysia

    Kuala Lumpur, 50300

Other trials in Malaysia

About this study

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

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?

Read more

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.

Read the detailed description

The aim of this clinical trial is to compare the rate of myopia progression as measured by change from dispensing, in axial length and the change from Baseline in the spherical equivalent cycloplegic autorefraction between a contact lens using A.R.R.E.S.T.® technology (test) and a single vision contact lens (control). Myopic children (7-15 years of age) will be randomly allocated to wear either test or control.

The overall trial duration, including follow-up period, is expected to be approximately 18 months. Each participant's duration is expected to be approximately 12 months.

The visits are Baseline, 1 week, 1 month, 3 months, 6 months, 9 months, and 12 months.

All procedures performed at these visits are standard, non invasive clinical tests.

Being tested
Single-vision contact lens, A.R.R.E.S.T.® contact lens
Keywords
axial length
Medical subject headings
Myopia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Single-vision contact lensDevice

    Standard single vision contact lens

  • A.R.R.E.S.T.® contact lensDevice

    Contact lens with edge pattern

Study groups in NCT06878118
Study groupRoleWhat they receive
Assigned Intervention 1Active comparatorSingle vision contact lens
Receives: Device: Single-vision contact lens
Assigned Intervention 2ExperimentalA.R.R.E.S.T.® contact lens
Receives: Device: A.R.R.E.S.T.® contact lens

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Axial Length

    Difference in change from baseline in axial length between each test and control.

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

  2. Cycloplegic spherical equivalent autorefraction

    Difference in change from Baseline in cycloplegic spherical equivalent autorefraction between each test and control.

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

Secondary outcomes (2)

  1. Visual performance as measured by high contrast visual acuity at 6 m

    Difference in visual acuity between each test and control.

    Measured: Baseline, then 1 week, 1 month, 3 months, 6 months, 9 months, 12 months after baseline

  2. Visual performance as measured by a non validated questionnaire based on a 1-10 numeric rating scale

    Difference in subjective visual performance between test and control after a minimum wear of one month.

    Measured: 1 month, 3 months, 6 months, 9 months, 12 months after baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Mar 2025
  2. Study start6 Jul 2025
  3. Primary completion1 Jun 2028 (estimated)
  4. Study completion1 Jun 2028 (estimated)

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06878118
Sponsor's protocol ID
nthal2024-03
Status last verified
Jul 2026
First submitted
10 Mar 2025
Last updated
31 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: There is no plan to make IPD available to other researchers.

Questions about this trial

What is this clinical trial studying?

A study testing Single-vision contact lens and A.R.R.E.S.T.® contact lens in people with Myopia and Myopia Progression, run by nthalmic Pty Ltd at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 43 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China, Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Axial Length (time frame: Baseline, then1 month, 3 months, 6 months, 9 months, and 12 months after baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06878118.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.

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The A.R.R.E.S.T.® Contact Lens Study (NCT06878118) | AzTrials