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

January 19, 2020 updated by: APP Vision Care Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 years to 15 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ticon Aspherical Daily Disposable Soft Contact Lens
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.
Device: soft contact lens
Placebo Comparator: Ticon Daily Soft Contact Lens
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.
Device: soft contact lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Spherical Equivalent Refraction (SER)
Time Frame: 12 months
The change in spherical equivalent refraction (SER) measured by cycloplegic autorefraction over 12 months.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Axial Eye Length (AXL)
Time Frame: 12 months
The change in axial eye length (AXL) measured over 12 months. Axial length is measured after cycloplegia using optical biometry.
12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary safety Endpoints
Time Frame: 12 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

APP Vision Care Inc.

Collaborators

National Taiwan University Hospital
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Investigators

  • Study Chair: Tzu-Hsun Tsai, M.D., National Taiwan University Hospital
  • Principal Investigator: Elizabeth P Shen, M.D., Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
  • Principal Investigator: Hsiao-Sang Chu, M.D., National Taiwan University Hospital
  • Principal Investigator: Han-Chih Cheng, M.D., Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 4, 2016

Primary Completion (Actual)

September 12, 2018

Study Completion (Actual)

June 6, 2019

Study Registration Dates

First Submitted

January 19, 2020

First Submitted That Met QC Criteria

January 19, 2020

First Posted (Actual)

January 23, 2020

Study Record Updates

Last Update Posted (Actual)

January 23, 2020

Last Update Submitted That Met QC Criteria

January 19, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1011128M

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Myopia

Clinical Trials on soft contact lens

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in United States

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe