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

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 ofthe study, and be willing and able to adhere to study requirements.

• Along with their parent / legal guardian, agree to maintain the visit and prescribedwearing schedule.

• Agree to wear allocated spectacles for a minimum of 5 days per week, at least 6hours per day for the duration of the study and to inform the investigator if theirschedule 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 0.10logMAR (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 activeparticipant 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 previouslyused 0.01% atropine are eligible for this study provided they agree not touse 0.01% atropine for at least 30 days before baseline and at any timeduring 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 ocularfindings / is known to affect a participant's ocular health / physiology either inan adverse or beneficial manner at enrolment and / or during the clinical trial.

• A known allergy to sodium fluorescein, benoxinate, proparacaine, tropicamide, orcyclopentolate.

• Strabismus as determined by cover test at distance (≥ 3 m) or near (40 cm) whilewearing 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 influencerefractive 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 notbe able to fulfil the clinical trial requirements or it is believed to be in theparticipant's best interests.