NCT06878118

The A.R.R.E.S.T.® Contact Lens Study

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: nthalmic Pty Ltd · Network
• Sex: All
• Age: 7 Years – 15 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Myopia
• Myopia Progression

Interventions

Type	Name	Description
DEVICE	Single-vision contact lens	Standard single vision contact lens
DEVICE	A.R.R.E.S.T.® contact lens	Contact lens with edge pattern

Timeline

• Start date: 2025-07-06
• Primary completion: 2026-05-01
• Completion: 2026-11-01
• First posted: 2025-03-14
• Last updated: 2025-10-03

Locations

2 sites across 2 countries: China, Malaysia