The A.R.R.E.S.T.® Contact Lens Study

NCT06878118 | Recruiting

• 1 other identifier: nthal2024-03
• Study Type: interventional
• Target: 80
• Locations: 2 countries
• Sites: 2

Brief 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.

Conditions

Myopia; Myopia Progression

Keywords

axial length

Outcome Measures

Primary Outcomes (2)

• Axial Length

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

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

• Cycloplegic spherical equivalent autorefraction

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

  Baseline, then 6 months, and 12 months after baseline

Secondary Outcomes (2)

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

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

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

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

Study Arms (2)

Assigned Intervention 1

ACTIVE COMPARATOR

Single vision contact lens

Device: Single-vision contact lens

Assigned Intervention 2

EXPERIMENTAL

A.R.R.E.S.T.® contact lens

Device: A.R.R.E.S.T.® contact lens

Interventions

Single-vision contact lens DEVICE

Standard single vision contact lens

Assigned Intervention 1

A.R.R.E.S.T.® contact lens DEVICE

Contact lens with edge pattern

Assigned Intervention 2

Eligibility Criteria

• Age: 7 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• nthalmic Pty Ltd: lead

Study Sites (2)

Wenzhou Medical University

Wenzhou, Zhejiang, 325000, China

RECRUITING

Optometry Clinic, Faculty of Health Science, Universiti Kebangsaan Malaysia

Kuala Lumpur, 50300, Malaysia

RECRUITING

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Central Study Contacts

Daniel Tilia, PhD

CONTACT

61290377700; emu@nthalmic.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2025
• First Posted: March 14, 2025
• Study Start: July 6, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: October 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1); MY (1)