The A.R.R.E.S.T.® Contact Lens Study

Not Applicable

Not yet recruiting

• Conditions: Myopia; Myopia Progression

• Registration Number: NCT06878118
• Lead Sponsor: nthalmic Pty Ltd

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.

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.

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-10
• Study First Submitted QC: 2025-03-13
• Last Update Submitted: 2025-03-13
• Study First Posted: 2025-03-14
• Last Update Posted: 2025-03-18
• Study Start: 2025-05-01
• Primary Completion: 2026-05-01
• Study Completion: 2026-11-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Axial Length	Baseline, then1 month, 3 months, 6 months, 9 months, and 12 months after baseline	Difference in change from baseline in axial length between each test and control.
Cycloplegic spherical equivalent autorefraction	Baseline, then 6 months, and 12 months after baseline	Difference in change from Baseline in cycloplegic spherical equivalent autorefraction between each test and control.

Secondary Outcome Measures

Name	Time	Method
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	Difference in visual acuity between each test and control.
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	Difference in subjective visual performance between test and control after a minimum wear of one month.

Trial Locations

Locations (2)

Wenzhou Medical University; 🇨🇳 Wenzhou, Zhejiang, China

Optometry Clinic, Faculty of Health Science, Universiti Kebangsaan Malaysia; 🇲🇾 Kuala Lumpur, Malaysia