NCT04238897

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2016

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 4, 2016

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 12, 2018

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 6, 2019

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 19, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 23, 2020

Completed
Last Updated

January 23, 2020

Status Verified

January 1, 2020

Enrollment Period

2.4 years

First QC Date

January 19, 2020

Last Update Submit

January 19, 2020

Conditions

Myopia

Keywords

myopia controlsoft contact lenseye diseases

Outcome Measures

Primary Outcomes (1)

  • Spherical Equivalent Refraction (SER)

    The change in spherical equivalent refraction (SER) measured by cycloplegic autorefraction over 12 months.

    12 months

Secondary Outcomes (1)

  • Axial Eye Length (AXL)

    12 months

Other Outcomes (1)

  • Primary safety Endpoints

    12 months

Study Arms (2)

Ticon Aspherical Daily Disposable Soft Contact Lens

EXPERIMENTAL

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

Ticon Daily Soft Contact Lens

PLACEBO COMPARATOR

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

Interventions

soft contact lensDEVICE
Ticon Aspherical Daily Disposable Soft Contact LensTicon Daily Soft Contact Lens

Eligibility Criteria

Age9 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 35737291DERIVED

MeSH Terms

Conditions

MyopiaEye Diseases

Interventions

Contact Lenses, Hydrophilic

Condition Hierarchy (Ancestors)

Refractive Errors

Intervention Hierarchy (Ancestors)

Contact LensesLensesOptical DevicesEquipment and Supplies

Study Officials

  • Tzu-Hsun Tsai, M.D.

    National Taiwan University Hospital

    STUDY CHAIR

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: paired-eye design
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 19, 2020

First Posted

January 23, 2020

Study Start

May 4, 2016

Primary Completion

September 12, 2018

Study Completion

June 6, 2019

Last Updated

January 23, 2020

Record last verified: 2020-01