Myopia Clinical Trial - Spectacle Films Utilising S.T.O.P.® Technology for

Status Recruiting

Clinical Trial Summary

There are two parts to this trial. First, to compare the rate of myopia progression of spectacle films using Spatio Temporal Optic Phase (S.T.O.P.®) technology that provide a dynamic optical cue against single vision spectacle lenses. Second, to compare the rate of myopia progression of spectacle films using S.T.O.P.® technology that provide a dynamic optical cue against spectacle films using S.T.O.P.® technology that provide a static optical cue. A dynamic optical cue is one that changes, and a static optical cue is one that does not change.

Clinical Trial Description

In the first part of the trial, myopic children (6-14 years of age) will be randomly allocated to wear one of three spectacle lens options (standard single vision spectacle lenses, standard single vision spectacle lenses + S.T.O.P.® Kit 1 spectacle films, or standard single vision spectacle lenses + S.T.O.P.® Kit 2 spectacle films). S.T.O.P.® spectacle films are applied to the front surface of standard single vision spectacle lenses. Both S.T.O.P.® Kits 1 and 2 are comprised of two different sets of spectacle films applied to two different pairs of single vision spectacle lenses which are worn on alternate weeks, and thus both S.T.O.P.® Kits 1 and 2 provide a dynamic optical cue. In the second part of this trial, participants will be randomly allocated wear of of two spectacle lens options (the best performer from S.T.O.P.® Kits 1 and 2 in terms of reducing the rate of myopic progression and single vision spectacle lenses + S.T.O.P.® film). As previously stated, both S.T.O.P.® Kits 1 and 2 provide a dynamic optical cue while S.T.O.P.® film provide a static optical cue. The overall trial duration, including follow-up period, is expected to be approximately 42 months. Each participant's duration is expected to be approximately 30 months. The visits are Baseline, Dispensing, 1 month, 4 months, 6 months, then visits every 6 months after. All procedures performed at these visits are standard, non invasive clinical tests. ;

Study Design

Related Conditions & MeSH terms

Myopia

Clinical Trial Details

NCT number	NCT06137560
Study type	Interventional
Source	nthalmic Pty Ltd
Contact	Daniel Tilia, MOptom, PhD
Phone	+6129037700
Email	d.tilia@nthalmic.com
Status	Recruiting
Phase	N/A
Start date	December 22, 2023
Completion date	September 2026

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Spectacle Films Utilising S.T.O.P.® Technology for Slowing Down Myopia Progression in Children

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms