To Evaluate the Efficacy and Safety of Aspherical Soft Contact Lens in Myopia Control

APP Vision Care

Status: Completed

Conditions: Myopia

Treatments: Device: soft contact lens

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04238897

1011128M

Details and patient eligibility

About

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

Full 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

Enrollment: 72 patients

Sex: All

Ages: 9 to 15 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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72 participants in 2 patient groups, including a placebo group

Ticon Aspherical Daily Disposable Soft Contact Lens

Experimental group

Description:

The subject will be requested to wear lens 8 hours a day, 5 days a week at least. The contact lens will be worn and replaced every day. All subjects will be followed for 1 year post device allocation with a brief clinical assessment at 1 day, 1 week, 1, 3, 6, 9, 12 months.

Treatment:

Device: soft contact lens

Ticon Daily Soft Contact Lens

Placebo Comparator group

Description:

The subject will be requested to wear lens 8 hours a day, 5 days a week at least. The contact lens will be worn and replaced every day. All subjects will be followed for 1 year post device allocation with a brief clinical assessment at 1 day, 1 week, 1, 3, 6, 9, 12 months.

Treatment:

Device: soft contact lens