The A.R.R.E.S.T.® Contact Lens Study

Sponsor
nthalmic Pty Ltd
Study ID
NCT06878118
Status
Recruiting
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Conditions

  • Myopia
  • Myopia Progression

Eligibility Criteria

Sex
ALL
Age
7 Years - 15 Years
Healthy Volunteers
Not accepted

Interventions

  • Single-vision contact lens — DEVICE
    Standard single vision contact lens
  • A.R.R.E.S.T.® contact lens — DEVICE
    Contact lens with edge pattern

Study Details

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.

Key Dates

First listed
Mar 14, 2025
Start date
Jul 6, 2025
Status verified
Sep 2025
Primary completion
May 1, 2026
Completion
Nov 1, 2026

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: Assigned Intervention 1
    Single vision contact lens
  • Experimental: Assigned Intervention 2
    A.R.R.E.S.T.® contact lens

Primary Outcome Measure

Axial Length [ Time Frame: Baseline, then1 month, 3 months, 6 months, 9 months, and 12 months after baseline ]

Central Contacts

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