Health TrialsbyHealthPanel

The A.R.R.E.S.T.® Contact Lens Study

ConditionsMyopiaMyopia Progression
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age7-15
Sponsornthalmic Pty Ltd

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Be between 7 to 15 years old inclusive at time of enrolment.

Read the Informed Assent.

Been explained the Informed Assent.

Indicated an understanding of the Informed Assent.

Disqualifiers

Participant in another study within 30 days prior to this study.

Bifocal / multifocal spectacles.

Bifocal / multifocal contact lenses.

Orthokeratology.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Single-vision contact lens

    Device

    Standard single vision contact lens

  • A.R.R.E.S.T.® contact lens

    Device

    Contact lens with edge pattern

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Assigned Intervention 1Active comparator 1 intervention
Group B: Assigned Intervention 2Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Axial Length

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

Time frame
Baseline, then1 month, 3 months, 6 months, 9 months, and 12 months after baseline
2

Cycloplegic spherical equivalent autorefraction

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

Time frame
Baseline, then 6 months, and 12 months after baseline

Secondary outcomes

1

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

Difference in visual acuity between each test and control.

Time frame
Baseline, then 1 week, 1 month, 3 months, 6 months, 9 months, 12 months after baseline
2

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

Difference in subjective visual performance between test and control after a minimum wear of one month.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

nthalmic Pty Ltd

Lead sponsor

Source ClinicalTrials.gov
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