Clinical trial NCT04238897: To Evaluate the Efficacy and Safety of Aspherical Soft Contact Lens in Myopia Control
Official title: A Prospective Randomized Control Study to Evaluate the Effect of Ticon Aspherical Daily Disposable Soft Contact Lens on Myopia Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Keywords: myopia control
soft contact lens
eye diseases
Lead sponsor: APP Vision Care Inc.
Sponsor class: INDUSTRY
Collaborators: name: National Taiwan University Hospital
name: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
First posted: 2020-01-23
Enrollment: 72
Sex: ALL
Minimum age (years): 9
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: paired-eye design
Primary purpose: TREATMENT

Brief summary: The objective of this study is to demonstrate that the Ticon Aspherical Daily Disposable Soft Contact Lens could retard myopia progress in youth

Detailed description: This study is designed as a prospective, multicenter, randomized, double blinded, controlled, paired-eye comparison study. At least 60 evaluable subjects with myopia progression ≧ 0.75 D in the past 12 months will be recruited from 2 study sites. The experimental soft contact lens with aspherical design (Ticon Aspherical) will be randomly assigned to either the right eye or the left eye of the subject , then the fellow eye will be assigned a control lens with a single vision distance (SVD) soft contact lens (Ticon). Both lenses will be worn at least 8 hours a day, 5 days a week for 1 year. All lenses will be replaced every day. Brief assessment of the clinical findings will be followed up for one year at 1 day, 1 week, 1, 3, 6, 9, 12 months upon allocation. The primary efficacy outcome is change in spherical equivalent refraction (SER) measured by cycloplegic autorefraction over 12 months. The secondary outcome is change in axial eye length (AXL) measured over 12 months. The secondary outcome measure is used to corroborate any changes in SER

Eligibility criteria: Inclusion Criteria:

* Myopia (SE) between -1.00D to -8.00D
* Astigmatism less than or equal to 1.75D
* Myopia progression ≧0.75 D in the past 12 months
* Best Corrected Visual Acuity (BCVA): 0.9 Snellen or better
* Willingness to wear contact lens constantly
* Availability for follow-up for at least 1 year
* Parent's understanding and acceptance
* have an acceptable surrogate capable of giving legally authorized consent on behalf of the subject

Exclusion Criteria:

* Anisometropia greater than 2.00D
* Presence of ocular disease preventing wear of contact lens
* Severe ocular or systemic allergies
* Taking any medication that might have an impact on contact lens wear or that might influence the outcome of the clinical trial
* Ocular or systemic condition that might affect refractive development
* Atropine/Pirenzepine treatment for myopia control in the past 1 month
* Prior use of Ortho-K lenses
* Dry eye with Schimer Test (basal secretion test) \< 5mm/5min or other physical condition that would contraindicate contact lens wear

Primary outcomes:
measure: Spherical Equivalent Refraction (SER)
timeFrame: 12 months
Secondary outcomes:
measure: Axial Eye Length (AXL)
timeFrame: 12 months
Other outcomes:
measure: Primary safety Endpoints
timeFrame: 12 months
Locations:
Study officials:
affiliation: National Taiwan University Hospital
name: Tzu-Hsun Tsai, M.D.
role: STUDY_CHAIR
affiliation: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
name: Elizabeth P Shen, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: National Taiwan University Hospital
name: Hsiao-Sang Chu, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
name: Han-Chih Cheng, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shen EP, Chu HS, Cheng HC, Tsai TH. Center-for-Near Extended-Depth-of-Focus Soft Contact Lens for Myopia Control in Children: 1-Year Results of a Randomized Controlled Trial. Ophthalmol Ther. 2022 Aug;11(4):1577-1588. doi: 10.1007/s40123-022-00536-5. Epub 2022 Jun 23.