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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Spectacle Films Utilising S.T.O.P.® Technology for Slowing Down Myopia Progression in Children: A Prospective, Masked, Controlled, Randomised, Clinical Trial.

Conditions
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Myopia

Intervention / Treatment
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* Device: Single vision spectacle lens
* Device: Single vision spectacle lens + S.T.O.P.® Kit 1
* Device: Single vision spectacle lens + S.T.O.P.® Kit 2
* Device: Single vision spectacle lens + S.T.O.P.® Film
* Device: Standard single vision spectacle lens + S.T.O.P.® Kit 1 or 2


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be between 6-14 years inclusive at time of enrolment. Have: Read the Informed Assent. Been explained the Informed Assent. Indicated an understanding of the Informed Assent. Signed the Informed Assent. Have their parent / legal guardian: Read the Informed Consent. Been explained the Informed Consent. Indicated an understanding of the Informed Consent. Signed the Informed Consent. Along with their parent / legal guardian, be capable of comprehending the nature of the study, and be willing and able to adhere to study requirements. Along with their parent / legal guardian, agree to maintain the visit and prescribed wearing schedule. Agree to wear allocated spectacles for a minimum of 5 days per week, at least 6 hours per day for the duration of the study and to inform the investigator if their schedule is interrupted. Possess wearable and visually functioning spectacles. Be in good general health, based on the parent's / legal guardian's knowledge. Have best-corrected high contrast visual acuity based on manifest refraction of 0.10 logMAR (20/25, 6/7.6) or better in each eye. Meet the following criteria determined by cycloplegic autorefraction at Baseline: -5.00 D ≤ spherical equivalent ≤ -0.75 D and sphere component ≤ -0.50 DS. -1.50 DC ≤ astigmatic component ≤ 0 DC. |Spherical equivalent anisometropia| ≤ 1.00 D. Exclusion Criteria: Participant is currently, or within 30 days prior to this study, has been an active participant in another study. Current or prior use of ANY form of myopia control, including but not limited to: Optical devices: Bifocal or multifocal spectacles of any type. Bifocal or multifocal contact lenses of any type. Orthokeratology of any type. Pharmacological agents: Atropine with a concentration > 0.01%. Participants who have previously used 0.01% atropine are eligible for this study provided they agree not to use 0.01% atropine for at least 30 days before baseline and at any time during the study. Pirenzepine Participant born earlier than 30 weeks or weighed < 1500 g at birth. A verbal report from the participant's parent / legal guardian is sufficient. Habitual use of a systemic or topical medication that may alter normal ocular findings / is known to affect a participant's ocular health / physiology either in an adverse or beneficial manner at enrolment and / or during the clinical trial. A known allergy to sodium fluorescein, benoxinate, proparacaine, tropicamide, or cyclopentolate. Strabismus as determined by cover test at distance (≥ 3 m) or near (40 cm) while wearing distance correction under non-cycloplegic conditions. Known ocular or systemic disease, such as but not limited to: Diabetes. Graves' disease. Glaucoma. Uveitis. Scleritis. Auto immune diseases such as ankylosing spondylitis, multiple sclerosis, Sjogrens syndrome, and systemic lupus erythematosus. Any ocular, systemic, or neuro-developmental conditions that could influence refractive development, such as but not limited to: Persistent pupillary membrane. Vitreous haemorrhage. Cataract. Central corneal scarring. Eyelid haemangiomas. Marfan's syndrome. Down's syndrome. Ehler's-Danlos syndrome. Stickler's syndrome. Ocular albinism. Retinopathy of prematurity. Keratoconus or irregular cornea. The investigator may, at their discretion, exclude anyone who they believe may not be able to fulfil the clinical trial requirements or it is believed to be in the participant's best interests.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Assigned Intervention 1<br>Single vision spectacle lens | Device: Single vision spectacle lens<br>* Standard single vision spectacle lens<br>|
| Experimental: Assigned Intervention 2<br>Single vision spectacle lens + S.T.O.P.® Kit 1 | Device: Single vision spectacle lens + S.T.O.P.® Kit 1<br>* Standard single vision spectacle lens + S.T.O.P.® Kit 1<br>|
| Experimental: Assigned Intervention 3<br>Single vision spectacle lens + S.T.O.P.® Kit 2 | Device: Single vision spectacle lens + S.T.O.P.® Kit 2<br>* Standard single vision spectacle lens + S.T.O.P.® Kit 2<br>|
| Active Comparator: Assigned Intervention 4<br>Static optical signal: single vision spectacle lens + S.T.O.P.® spectacle film | Device: Single vision spectacle lens + S.T.O.P.® Film<br>* Standard single vision spectacle lens + S.T.O.P.® Film<br>|
| Experimental: Assigned Intervention 5<br>Dynamic optical signal: single vision spectacle lens + S.T.O.P.® Kit 1 or 2 | Device: Standard single vision spectacle lens + S.T.O.P.® Kit 1 or 2<br>* Standard single vision spectacle lens + S.T.O.P.® Kit 1 or 2<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Axial length | Difference in change from Baseline in axial length between single vision (control) and S.T.O.P.® Kit 1 & 2 (tests) | Baseline, First Dispense (up to 26 days from Baseline), then 1 month, 4 months, and 6 months after First Dispense | 
| Axial length | Difference in change from Second Dispense in axial length between static optical cue (control) and dynamic optical cue (test) | Second Dispense (up to 392 days from Baseline), then 6 months, 12 months, and 18 months after Second Dispense | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cycloplegic spherical equivalent autorefraction | Difference in change from Baseline in cycloplegic spherical equivalent autorefraction between single vision (control) and S.T.O.P.® Kit 1 & 2 (tests) | Baseline, First Dispense (up to 26 days from Baseline), then 1 month, 4 months, and 6 months after First Dispense | 
| Cycloplegic spherical equivalent autorefraction | Difference in change from Second Dispense in cycloplegic spherical equivalent autorefraction between static optical cue (control) and dynamic optical cue (test) | Second Dispense (up to 392 days from Baseline), then 6 months, 12 months, and 18 months after Second Dispense | 
| Visual performance as measured by high contrast visual acuity at 6 m | Difference in visual performance between single vision (control) and S.T.O.P.® Kit 1 & 2 (tests) | 1 month, 4 months, and 6 months after First Dispense (up to 26 days from Baseline) | 
| Visual performance as measured by high contrast visual acuity at 6 m | Difference in visual performance between static optical cue (control) and dynamic optical cue (test) | 6 months, 12 months, and 18 months after Second Dispense (up to 392 days from Baseline) | 
| Visual performance as measured by a non validated questionnaire based on a 1-10 | Difference in visual performance between single vision (control) and S.T.O.P.® Kit 1 & 2 (tests) | 1 month, 4 months, and 6 months after First Dispense (up to 26 days from Baseline) | 
| Visual performance as measured by a non validated questionnaire based on a 1-10 | Difference in visual performance between static optical cue (control) and dynamic optical cue (test) | 6 months, 12 months, and 18 months after Second Dispense (up to 26 days from Baseline) |