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

NCT05243836 | Active Not Recruiting

• 1 other identifier: nthal2021-01
• Study Type: interventional
• Target: 441
• Locations: 3 countries
• Sites: 7

Brief Summary

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

Conditions

Myopia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• Cycloplegic spherical equivalent autorefraction

  Baseline, 12 months, 24 months, 36 months

• Visual performance as measured by high contrast visual acuity at 6 m

  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

  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

  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

  1 week, 1 month, 6 months, 12 months, 18 months , 24 months, 30 months, 36 months

Study Arms (3)

MiSight®

ACTIVE COMPARATOR

MiSight® Contact Lens (Omafilcon A, 60% water)

Device: MiSight®

S.T.O.P® F2

EXPERIMENTAL

S.T.O.P® F2 Contact Lens (Ocufilcon D, 55% water)

Device: S.T.O.P® F2

S.T.O.P® DT

EXPERIMENTAL

S.T.O.P® DT Contact Lens (Ocufilcon D, 55% water)

Device: S.T.O.P® DT

Interventions

S.T.O.P® DT DEVICE

Ocufilcon D, 55% water

S.T.O.P® DT

MiSight® DEVICE

Omafilcon A (60% water)

MiSight®

S.T.O.P® F2 DEVICE

Ocufilcon D, 55% water

S.T.O.P® F2

Eligibility Criteria

• Age: 8 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• nthalmic Pty Ltd: lead
• Brighten Optix Corporation: collaborator

Study Sites (7)

Wenzhou Medical University Eye Hospital

Wenzhou, Lucheng District, 325027, China

Location

Tianjin Medical University

Tianjin, Wuqing District, 300384, China

Location

Shanghai Fudan University Eye and ENT Hospital

Shanghai, Xuhui District, 200031, China

Location

LV Prasad Eye Institute

Hyderabad, Telangana, 500034, India

Location

Centre Universitari de la Visió

Terrassa, Barcelona, 08222, Spain

Location

Lab. de Superficie Ocular y Lentes de Contacto (SOYLC)

Santiago de Compostela, Galicia, 15899, Spain

Location

Ocupharm Research Group (Clinica Universitaria de Optometría), Universidad Complutense Madrid

Madrid, 28037, Spain

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• Daniel Tilia, MOptom, PhD

  nthalmic Pty Ltd

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2022
• First Posted: February 17, 2022
• Study Start: August 4, 2023
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3); IN (1); ES (3)