Clinical trial NCT05243836: S.T.O.P.® Technology Contact Lenses Versus Dual-focus Contact Lenses for Slowing Down Myopia Progression in Children
Official title: 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, Masked, Randomised, Non Inferiority Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Myopia
Lead sponsor: nthalmic Pty Ltd
Sponsor class: NETWORK
Collaborators: name: Brighten Optix Corporation
First posted: 2022-02-17
Enrollment: 441
Sex: ALL
Minimum age (years): 8
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Axial Length
timeFrame: Baseline, 1 month, 6 months, 12 months, 18 months , 24 months, 30 months, 36 months
Secondary outcomes:
measure: Cycloplegic spherical equivalent autorefraction
timeFrame: Baseline, 12 months, 24 months, 36 months
measure: Visual performance as measured by high contrast visual acuity at 6 m
timeFrame: 1 week, 1 month, 6 months, 12 months, 18 months , 24 months, 30 months, 36 months
measure: 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
timeFrame: 1 week, 1 month, 6 months, 12 months, 18 months , 24 months, 30 months, 36 months
measure: Bulbar hyperemia graded on a 0-4 scale in 0.5- steps where a higher grading indicates increased hyperemia
timeFrame: 1 week, 1 month, 6 months, 12 months, 18 months , 24 months, 30 months, 36 months
measure: Limbal hyperemia graded on a 0-4 scale in 0.5- steps where a higher grading indicates increased hyperemia
timeFrame: 1 week, 1 month, 6 months, 12 months, 18 months , 24 months, 30 months, 36 months
measure: Palpebral roughness graded on a 0-4 scale in 0.5- steps where a higher grading indicates increased roughness
timeFrame: 1 week, 1 month, 6 months, 12 months, 18 months , 24 months, 30 months, 36 months
measure: Corneal staining graded on a 0-4 scale in 0.5- steps where a higher grading indicates increased staining
timeFrame: 1 week, 1 month, 6 months, 12 months, 18 months , 24 months, 30 months, 36 months
measure: Conjunctival staining graded on a 0-4 scale in 0.5- steps where a higher grading indicates increased staining
timeFrame: 1 week, 1 month, 6 months, 12 months, 18 months , 24 months, 30 months, 36 months
measure: Binocular vision as measured by heterophoria in prism diopters at 3 m
timeFrame: 1 week, 6 months, 18 months, 30 months
measure: Binocular vision as measured by heterophoria in prism diopters at 40 cm
timeFrame: 1 week, 6 months, 18 months, 30 months
measure: Binocular vision as measured by monocular accommodative facility (+/-2.00 D flipper) in cycles per minute at 40 cm
timeFrame: 1 week, 6 months, 18 months, 30 months
measure: Binocular vision as measured by monocular accommodative response in diopters at 40 cm
timeFrame: 1 week, 6 months, 18 months, 30 months
measure: Corneal topography as measured by flat keratometry measurement in diopters
timeFrame: Baseline, 12 months, 36 months
measure: Corneal topography as measured by steep keratometry measurement in diopters
timeFrame: Baseline, 12 months, 36 months
Other outcomes:
Locations:
city: Wenzhou
country: China
facility: Wenzhou Medical University Eye Hospital
state: Lucheng District
city: Tianjin
country: China
facility: Tianjin Medical University
state: Wuqing District
city: Shanghai
country: China
facility: Shanghai Fudan University Eye and ENT Hospital
state: Xuhui District
city: Hyderabad
country: India
facility: LV Prasad Eye Institute
state: Telangana
city: Hyderabad
country: India
facility: The University of Hyderabad
state: Telangana
city: Terrassa
country: Spain
facility: Centre Universitari de la Visió
state: Barcelona
city: Santiago De Compostela
country: Spain
facility: Lab. de Superficie Ocular y Lentes de Contacto (SOYLC)
state: Galicia
city: Madrid
country: Spain
facility: Ocupharm Research Group (Clinica Universitaria de Optometría), Universidad Complutense Madrid
Study officials:
affiliation: nthalmic Pty Ltd
name: Daniel Tilia, MOptom, PhD
role: PRINCIPAL_INVESTIGATOR
References: