S.T.O.P.® Technology Contact Lenses Versus Dual-focus Contact Lenses for Slowing Down Myopia Progression in Children

Study Overview
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Brief Summary
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To compare the rate of myopia progression of contact lenses utilising S.T.O.P.® technology against MiSight® contact lenses.

Detailed Description
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Myopic children (8-14 years of age) will be randomly allocated to wear one of 3 contact lens options (MiSight®, S.T.O.P.®- F2 or S.T.O.P.®- DT) bilaterally on a daily wear basis. The overall trial duration, including follow-up period, is expected to be approximately 48 months. Each participant's duration is expected to be approximately 36 months. The visits are Baseline / Fit, Dispensing, 1 week, 1 month, 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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Contact Lenses Utilising S.T.O.P.® Technology Versus Dual-focus Contact Lenses for Slowing Down Myopia Progression in Children: A Three-year Prospective, Multi-centre, Controlled, Double-masked, Randomised, Non Inferiority Clinical Trial

Conditions
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Myopia

Intervention / Treatment
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* Device: S.T.O.P® F2
* Device: S.T.O.P® DT
* Device: MiSight®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be between 8-14. 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 schedule . Agree to wear allocated contact lenses for a minimum of 5 days per week, at least 6 hours per day on days lenses are worn but not > 16 hours per day, and to remove lenses at night (i.e., daily wear only with no contact lens wear during sleep), for their duration of the study and to inform the investigator if their schedule is interrupted. Wearing time can be modified by the investigator for health reasons. 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: Spherical equivalent between -0.75 to -4.00 D inclusive. Astigmatism ≥ -1.00 D. *participants who fail astigmatism criterion with autorefraction pass astigmatism criterion if ≥ -0.75 D is measured with subjective refraction. 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 / multifocal spectacles of any type. Bifocal / multifocal contact lenses of any type. Orthokeratology of any type. Pharmacological agents. European and Indian sites: Atropine. Chinese sites: 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. Habitual use of a systemic or topical medication that may alter normal ocular findings / is known to affect a participant's ocular health / physiology or contact lens performance either in an adverse or beneficial manner at enrolment and / or during the clinical trial. A known allergy to sodium fluorescein, benoxinate, proparacaine, or tropicamide. Chinese sites: A known allergy to cyclopentolate. A known corneal hypoesthesia (reduced corneal sensitivity), corneal ulcer, corneal infiltrates, ocular viral or fungal infections, or any other recurrent ocular infections. Strabismus 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. Biomicroscopic that contraindicate contact lens, such as but limited to: Neovascularisation or ghost vessels ≥ 1.5 mm in from limbus. Any active anterior segment disease that contraindicates safe contact lens wear. Clinically significant giant papillary conjunctivitis. Clinically significant abnormalities of the anterior segment, lids, conjunctiva, sclera, or associated structures. Allergic or seasonal conjunctivitis if the investigator believes it could significantly interfere with maintaining a specified wearing schedule. 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: 8 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: MiSight®<br>MiSight® Contact Lens (Omafilcon A, 60% water) | Device: MiSight®<br>* Omafilcon A (60% water)<br>|
| Experimental: S.T.O.P® F2<br>S.T.O.P® F2 Contact Lens (Ocufilcon D, 55% water) | Device: S.T.O.P® F2<br>* Ocufilcon D, 55% water<br>|
| Experimental: S.T.O.P® DT<br>S.T.O.P® DT Contact Lens (Ocufilcon D, 55% water) | Device: S.T.O.P® DT<br>* Ocufilcon D, 55% water<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 test and control contact lenses. | Baseline, 1 month, 6 months, 12 months, 18 months , 24 months, 30 months, 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cycloplegic spherical equivalent autorefraction | Difference in change from baseline in spherical equivalent autorefraction between test and control contact lenses. | Baseline, 12 months, 24 months, 36 months | 
| Visual performance as measured by high contrast visual acuity at 6 m | Differences in visual performance between test and control contact lenses | 1 week, 1 month, 6 months, 12 months, 18 months , 24 months, 30 months, 36 months | 
| Visual performance as measured by a non validated questionnaire based on a 1-10 numeric rating scale where a higher score indicates a better outcome | Differences in visual performance between test and control contact lenses | 1 week, 1 month, 6 months, 12 months, 18 months , 24 months, 30 months, 36 months | 
| Bulbar hyperemia graded on a 0-4 scale in 0.5- steps where a higher grading indicates increased hyperemia | Differences in bulbar hyperemia grading between test and control contact lenses. | 1 week, 1 month, 6 months, 12 months, 18 months , 24 months, 30 months, 36 months | 
| Limbal hyperemia graded on a 0-4 scale in 0.5- steps where a higher grading indicates increased hyperemia | Differences in limbal hyperemia grading between test and control contact lenses. | 1 week, 1 month, 6 months, 12 months, 18 months , 24 months, 30 months, 36 months | 
| Palpebral roughness graded on a 0-4 scale in 0.5- steps where a higher grading indicates increased roughness | Differences in palpebral roughness grading between test and control contact lenses. | 1 week, 1 month, 6 months, 12 months, 18 months , 24 months, 30 months, 36 months | 
| Corneal staining graded on a 0-4 scale in 0.5- steps where a higher grading indicates increased staining | Differences in corneal staining grading between test and control contact lenses. | 1 week, 1 month, 6 months, 12 months, 18 months , 24 months, 30 months, 36 months | 
| Conjunctival staining graded on a 0-4 scale in 0.5- steps where a higher grading indicates increased staining | Differences in conjunctival staining grading between test and control contact lenses. | 1 week, 1 month, 6 months, 12 months, 18 months , 24 months, 30 months, 36 months | 
| Binocular vision as measured by heterophoria in prism diopters at 3 m | Differences in heterophoria at 3 m between test and control contact lenses. | 1 week, 6 months, 18 months, 30 months | 
| Binocular vision as measured by heterophoria in prism diopters at 40 cm | Differences in heterophoria at 40 cm between test and control contact lenses. | 1 week, 6 months, 18 months, 30 months | 
| Binocular vision as measured by monocular accommodative facility (+/-2.00 D flipper) in cycles per minute at 40 cm | Differences in monocular accommodative facility at 40 cm between test and control contact lenses. | 1 week, 6 months, 18 months, 30 months | 
| Binocular vision as measured by monocular accommodative response in diopters at 40 cm | Differences in monocular accommodative response at 40 cm between test and control contact lenses. | 1 week, 6 months, 18 months, 30 months | 
| Corneal topography as measured by flat keratometry measurement in diopters | Differences in flat keratometry measurements between test and control contact lenses. | Baseline, 12 months, 36 months | 
| Corneal topography as measured by steep keratometry measurement in diopters | Differences in steep keratometry measurements between test and control contact lenses. | Baseline, 12 months, 36 months |