MyopiaX Treatment for the Reduction of Myopia Progression in Children and Adolescents: Safety and Efficacy Investigation (MyopiaX-1)

• ClinicalTrials.gov Identifier: NCT04967287
• Recruitment Status: Active, not recruiting
• First Posted: July 19, 2021
• Last Update Posted: February 20, 2024
• Sponsor: Dopavision GmbH
• Information provided by (Responsible Party): Dopavision GmbH

Tracking Information

• First Submitted Date: July 7, 2021
• First Posted Date: July 19, 2021
• Last Update Posted Date: February 20, 2024
• Actual Study Start Date: November 16, 2021
• Estimated Primary Completion Date: April 30, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 19, 2023)

Change in axial length and in spherical equivalent refractive error [ Time Frame: 6 months ]

Change in axial length (mm) and in spherical equivalent refractive error )D)from baseline to month 6.

Original Primary Outcome Measures (submitted: July 16, 2021)

Change in spherical equivalent refraction [ Time Frame: 24 months ]

Change in spherical equivalent refraction (D) from baseline to 24 months as measured by cycloplegic autorefraction.

• Current Secondary Outcome Measures: Not Provided

Original Secondary Outcome Measures (submitted: July 16, 2021)

• Change in axial length [ Time Frame: 24 months ]
  Change in axial lenght (mm) from baseline to 24 months as measured by optical low-coherence interferometry
• Change in spherical equivalent refraction [ Time Frame: 12 months ]
  Change in spherical equivalent refraction (D) from baseline to 12 months as measured by cycloplegic autorefraction
• Changes in axial length [ Time Frame: 6, 12, and 18 months ]
  Changes in axial length (mm) from baseline to 6, 12, and18 months as measured by optical low-coherence interferometry
• Parent reported outcome - satisfaction with MyopiaX [ Time Frame: 12 and 24 months ]
  Questionnaire created to evaluate parents satisfaction with the device and treatment concept

Current Other Pre-specified Outcome Measures (submitted: January 19, 2023)

• Change in axial length and in spherical equivalent refractive error [ Time Frame: 12 months ]
  Change in axial length (mm) and spherical equivalent refractive error (D) from month 6 to month 12
• Retinal and choroidal imaging parameters [ Time Frame: 12 months ]
  Retinal and choriodal parameters during the course of the trial
• Device usability as measured with the user feedback questionnaire [ Time Frame: 12 months ]
  Device usability as measured with the user feedback questionnaire at the end of the study

• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: MyopiaX Treatment for the Reduction of Myopia Progression in Children and Adolescents: Safety and Efficacy Investigation
• Official Title: MyopiaX Treatment for the Reduction of Myopia Progression in Children and Adolescents: Safety and Efficacy Investigation
• Brief Summary: The purpose of this trial is to investigate the safety and efficacy of MyopiaX - a digital treatment intended to slow the progression of myopia in children and adolescents.

Detailed Description

The present study is a multicentric, randomized, controlled, single masked trial to investigate the signals of effect, the safety and tolerability of MyopiaX in slowing the progression of myopia.

The trial consists of 12 months treatment period. The first 6 months participants will be treated either with MyopiaX or with myopia control spectacles. During the second half of the trial, participants treated with MyopiaX will receive the myopia control spectacles in addition. 81 children and adolescent aged 6 - 12 years will be included in the trial. Eligible subjects will be randomly assigned in a 2:1 ratio to either the MyopiaX or the myopia control spectacles group.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment
• Condition: Myopia

Intervention

• Device: MyopiaX
  MyopiaX treatment twice a day
• Device: Myopia control spectacles
  To be used all as prescribed

Study Arms

• Experimental: MyopiaX
  MyopiaX treatment
  Intervention: Device: MyopiaX
• Active Comparator: Myopia control spectacles
  Clinically validated treatment to control myopia
  Intervention: Device: Myopia control spectacles

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: September 14, 2023): 124
• Original Estimated Enrollment (submitted: July 16, 2021): 234
• Estimated Study Completion Date: November 30, 2024
• Estimated Primary Completion Date: April 30, 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Myopic children (-0.75 to -5.0 D SER, least myopic meridian -0.50 D in each eye)
• At least VA 0.2 LogMAR in each eye
• Age: 6 - 12 years old
• Good tolerability of test session with VR system
• Binocular adequacy as tested with VR
• Ability to understand treatment and give valid assent

Exclusion Criteria:

• Concomitant or previous therapies for myopia
• Eye diseases/conditions:
• Anisometropia ≥ 1.5 D
• Astigmatism ≥ 3 D
• Ophthalmological comorbidities
• Optic nerve abnormalities
• Suspicion of syndromic or monogenetic myopia
• Systemic illnesses affecting eye health, eye growth, and/or refraction
• Any illnesses affecting dopamine function (e.g., sleep disorder)
• Medication affecting dopamine function, accommodation, pupil size, or having an impact on the ocular surface (such as allergy medications)
• Participation in other clinical studies
• Medical history (or family history) of photosensitive epilepsy

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 6 Years to 12 Years (Child)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Germany, Netherlands, Portugal, Spain, United Kingdom
• Removed Location Countries: Ireland

Administrative Information

• NCT Number: NCT04967287
• Other Study ID Numbers: MyopiaX-1
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Dopavision GmbH
• Original Responsible Party: Same as current
• Current Study Sponsor: Dopavision GmbH
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Chair: Ian Flitcroft, Prof.; Centre for Eye Reserach Ireland, Technological University Dublin

• PRS Account: Dopavision GmbH
• Verification Date: September 2023