Ignite Creation Date:
2025-12-25 @ 4:32 AM
Ignite Modification Date:
2025-12-26 @ 3:34 AM
Study NCT ID:
NCT06878118
Status:
RECRUITING
Last Update Posted:
2025-10-03
First Post:
2025-03-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The A.R.R.E.S.T.® Contact Lens Study
Sponsor:
nthalmic Pty Ltd
Organization:
Study Overview
Official Title:
Prospective, Controlled, Randomised, Contralateral Wear, Dispensing Trial to Assess the Efficacy of Contact Lenses Using A.R.R.E.S.T.® Technology
Status:
RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: