Clinical trial NCT06137560: Spectacle Films Utilising S.T.O.P.® Technology for Slowing Down Myopia Progression in Children
Official title: Spectacle Films Utilising S.T.O.P.® Technology for Slowing Down Myopia Progression in Children: A Prospective, Masked, Controlled, Randomised, Clinical Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Myopia
Lead sponsor: nthalmic Pty Ltd
Sponsor class: NETWORK
Collaborators: name: Zhong Jing Wei Shi (Suzhou) Optical Technology Ltd.
First posted: 2023-11-18
Enrollment: 210
Sex: ALL
Minimum age (years): 6
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Axial length
timeFrame: Baseline, First Dispense (up to 26 days from Baseline), then 1 month, 4 months, and 6 months after First Dispense
measure: Axial length
timeFrame: Second Dispense (up to 392 days from Baseline), then 6 months, 12 months, and 18 months after Second Dispense
Secondary outcomes:
measure: Cycloplegic spherical equivalent autorefraction
timeFrame: Baseline, First Dispense (up to 26 days from Baseline), then 1 month, 4 months, and 6 months after First Dispense
measure: Cycloplegic spherical equivalent autorefraction
timeFrame: Second Dispense (up to 392 days from Baseline), then 6 months, 12 months, and 18 months after Second Dispense
measure: Visual performance as measured by high contrast visual acuity at 6 m
timeFrame: 1 month, 4 months, and 6 months after First Dispense (up to 26 days from Baseline)
measure: Visual performance as measured by high contrast visual acuity at 6 m
timeFrame: 6 months, 12 months, and 18 months after Second Dispense (up to 392 days from Baseline)
measure: Visual performance as measured by a non validated questionnaire based on a 1-10
timeFrame: 1 month, 4 months, and 6 months after First Dispense (up to 26 days from Baseline)
measure: Visual performance as measured by a non validated questionnaire based on a 1-10
timeFrame: 6 months, 12 months, and 18 months after Second Dispense (up to 26 days from Baseline)
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Eye Hospital
state: Heping District
city: Shanghai
country: China
facility: Shanghai Fudan University Eye and ENT Hospital
state: Xuhui District
city: Surat
country: India
facility: Divyajyoti Trust Tejas Eye Hospital
state: Gujarat
city: Hyderabad
country: India
facility: LV Prasad Eye Institute
state: Telangana
city: Hyderabad
country: India
facility: Pristine Eye Hospitals
state: Telangana
Study officials:
affiliation: nthalmic Pty Ltd
name: Daniel Tilia, Optom, PhD
role: PRINCIPAL_INVESTIGATOR
References: