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

Myopia Clinical Trial

Official title:

A Prospective Randomized Control Study to Evaluate the Effect of Ticon Aspherical Daily Disposable Soft Contact Lens on Myopia Control

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04238897
• Other study ID #: 1011128M
• Status: Completed
• Phase: N/A
• Start date: May 4, 2016
• Est. completion date: June 6, 2019

Study information

• Verified date: January 2020
• Source: APP Vision Care Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: June 6, 2019
• Est. primary completion date: September 12, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Years to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• soft contact lens

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
APP Vision Care Inc.	National Taiwan University Hospital, Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Primary safety Endpoints	All dispensed eyes over all follow-up visits. Measured on a scale of 0-4 with 0=no findings and 4=severe findings. Epithelial edema, epithelial microcysts, corneal staining, limbal & bulbar injection, conjunctival abnormalities, corneal neovascularization and infiltrates will be measured.	12 months
Primary	Spherical Equivalent Refraction (SER)	The change in spherical equivalent refraction (SER) measured by cycloplegic autorefraction over 12 months.	12 months
Secondary	Axial Eye Length (AXL)	The change in axial eye length (AXL) measured over 12 months. Axial length is measured after cycloplegia using optical biometry.	12 months