NCT03413085

Brief Summary

The objective of this study is to investigate the efficacy and safety of soft lens in myopia control.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
59

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2018

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

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

First Submitted

Initial submission to the registry

January 21, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 29, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

May 2, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 5, 2020

Completed
Last Updated

March 12, 2020

Status Verified

March 1, 2020

Enrollment Period

1.7 years

First QC Date

January 21, 2018

Last Update Submit

March 10, 2020

Conditions

Myopia

Keywords

Myopia control

Outcome Measures

Primary Outcomes (2)

  • Objective cycloplegic refractive error

    Changes in objective cycloplegic refractive error between the two eyes in 48 weeks

    48 weeks

  • Axial length

    Changes in axial length between the two eyes in 48 weeks

    48 weeks

Secondary Outcomes (6)

  • Cycloplegic refractive error

    12, 24, and 36 weeks

  • Axial length

    12, 24, and 36 weeks

  • Myopia progression and axial elongation

    during 48 weeks

  • Self-assessment by questionnaire 1

    during 48 weeks

  • Self-assessment by questionnaire 2

    during 48 weeks

  • +1 more secondary outcomes

Study Arms (2)

Group A

OTHER

Intervention name: multifocal soft contact lens/single vision soft contact lens Left eye: multifocal soft contact lens Right eye: single vision soft contact lens

Device: soft contact lens

Group B

OTHER

Intervention name: multifocal soft contact lens/single vision soft contact lens Left eye: single vision soft contact lens Right eye: multifocal soft contact lens

Device: soft contact lens

Interventions

soft contact lensDEVICE

Group A Group B

Group AGroup B

Eligibility Criteria

Age6 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Both genders aged between 6 and 15 years
  • Spherical equivalent refractive error between -1.00D and -10.00D
  • Visual acuity with contact lens of 20/25 or better in each eye
  • Astigmatism less than or equal to 1.50D
  • Anisometropia less than or equal to 1.00D
  • Agree to wear assigned contact lens and able to comply with the study protocol
  • Subjects and/or their legal representatives agree to sign informed consent form

You may not qualify if:

  • Eye disease or vision problem that may contraindicate/interfere with contact lens wearing, for example:
  • Amblyopia
  • Severe strabismus at investigator's discretion
  • Pathologically dry eye
  • Aphakia
  • Slit lamp findings including but not limited to corneal edema, corneal ulcer, bulbar redness that are more serious than grade 1
  • Currently ocular infection of any type or inflammation in either eye
  • Oculomotor nerve palsies
  • Pupil or lid abnormality in either eye
  • Severe ocular allergy
  • Anterior segment infection, inflammation or abnormality
  • Corneal vascularization greater than 1 mm of penetration
  • History of herpetic keratitis
  • Use of bifocals, progressive addition lenses, rigid gas permeable contact lenses, orthokeratology lenses, atropine, pirenzepine or any other myopia control treatment within 1 month prior to screening visit
  • Systemic disease that may affect vision or contact lens wearing (e.g. diabetes, Down syndrome), autoimmune disease, infectious disease, or immunosuppressive diseases recorded in medical charts or informed by caregiver
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Tzu-Hsun Tsai M.D.

Taipei, 100, Taiwan

Location

Ken-Kuo Lin M.D.

Taipei, 105, Taiwan

Location

Jiahn-Shing Lee M.D.

Taoyuan District, 333, Taiwan

Location

MeSH Terms

Conditions

Myopia

Interventions

Contact Lenses, Hydrophilic

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Intervention Hierarchy (Ancestors)

Contact LensesLensesOptical DevicesEquipment and Supplies

Study Officials

  • Tzu-Hsun Tsai, M.D.

    National Taiwan University Hospital

    STUDY CHAIR

  • Tzu-Hsun Tsai, M.D.

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

  • Chao-Wen Lin, M.D.

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

  • Ken-Kuo Lin, M.D.

    Taipei Chang Gung Memorial Hospital

    PRINCIPAL INVESTIGATOR

  • Jiahn-Shing Lee, M.D.

    Chang Gung Memorial Hospital

    PRINCIPAL INVESTIGATOR

  • Chiun-Ho Hou, M.D.

    Chang Gung Memorial Hospital

    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 comparison
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2018

First Posted

January 29, 2018

Study Start

May 2, 2018

Primary Completion

December 31, 2019

Study Completion

March 5, 2020

Last Updated

March 12, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

TW(3)