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

Primary Purpose

Myopia

Status

Completed

Phase

Not Applicable

Locations

Taiwan

Study Type

Interventional

Intervention

soft contact lens

About this trial

This is an interventional treatment trial for Myopia focused on measuring Myopia control

Eligibility Criteria

6 Years - 15 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

Eye disease or vision problem that may contraindicate/interfere with contact lens wearing, for example:
1. Amblyopia
2. Severe strabismus at investigator's discretion
3. Pathologically dry eye
4. Aphakia
5. Slit lamp findings including but not limited to corneal edema, corneal ulcer, bulbar redness that are more serious than grade 1
6. Currently ocular infection of any type or inflammation in either eye
7. Oculomotor nerve palsies
8. Pupil or lid abnormality in either eye
9. Severe ocular allergy
10. Anterior segment infection, inflammation or abnormality
11. Corneal vascularization greater than 1 mm of penetration
12. 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
Surgically altered eyes (e.g. corneal or refractive surgery, not including stye removal surgery)
Receiving any medication for long-term use which may interfere with contact lens wearing, tear film production, pupil size, accommodation or refractive state, such as nasal decongestants (e.g. pseudoephedrine, phenylephrine), antihistamines (e.g. chlorpheniramine, diphenhydramine), Prednisolone or Ritalin (methyphenidate)

Sites / Locations

Tzu-Hsun Tsai M.D.
Ken-Kuo Lin M.D.
Jiahn-Shing Lee M.D.

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

Group A

Group B

Arm Description

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

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

Outcomes

Primary Outcome Measures

Objective cycloplegic refractive error

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

Axial length

Changes in axial length between the two eyes in 48 weeks

Secondary Outcome Measures

Cycloplegic refractive error

Changes in objective cycloplegic refractive error between the two eyes from baseline after treatment

Axial length

Changes in axial length between the two eyes from baseline after treatment

Myopia progression and axial elongation

Percent reductions of myopia progression and axial elongation

Self-assessment by questionnaire 1

Analysis of subject self-assessment

Self-assessment by questionnaire 2

Average wearing hours across the study period

Self-assessment by questionnaire 3

Reasons and rate for discontinued wear during the study period

Full Information

NCT ID

NCT03413085

First Posted

January 21, 2018

Last Updated

March 10, 2020

Sponsor

Largan Medical Co., Ltd.

Collaborators

National Taiwan University Hospital, Chang Gung Memorial Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03413085

Brief Title

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

Official Title

A Prospective, Randomization, Double-blind Study to Evaluate the Efficacy and Safety of Multifocal Soft Contact Lens in Myopia Control

Study Type

Interventional

2. Study Status

Record Verification Date

March 2020

Overall Recruitment Status

Completed

Study Start Date

May 2, 2018 (Actual)

Primary Completion Date

December 31, 2019 (Actual)

Study Completion Date

March 5, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Largan Medical Co., Ltd.

Collaborators

National Taiwan University Hospital, Chang Gung Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

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

Detailed Description

This is a prospective, randomized, paired eye comparison, double-blind study aims to evaluate the efficacy and safety of "Soft Lens" in myopia control among schoolchildren. A total of 118 eyes are planned to be enrolled and the expect duration of subject participation will be 48 weeks not including two weeks of screening period. Data such as refractive error, axial length, visual acuity, average wearing hours, self-assessment, adverse events etc. will be collected during the study. A total of 10 visits, i.e. a screening visit, a randomization visit, and 8 treatment visits are planned. Subjects will be encouraged to complete all planned visits.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Myopia

Keywords

Myopia control

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Paired-eye comparison

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

59 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group A

Arm Type

Other

Arm Description

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

Arm Title

Group B

Arm Type

Other

Arm Description

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

Intervention Type

Device

Intervention Name(s)

soft contact lens

Intervention Description

Group A Group B

Primary Outcome Measure Information:

Title

Objective cycloplegic refractive error

Description

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

Time Frame

48 weeks

Title

Axial length

Description

Changes in axial length between the two eyes in 48 weeks

Time Frame

48 weeks

Secondary Outcome Measure Information:

Title

Cycloplegic refractive error

Description

Changes in objective cycloplegic refractive error between the two eyes from baseline after treatment

Time Frame

12, 24, and 36 weeks

Title

Axial length

Description

Changes in axial length between the two eyes from baseline after treatment

Time Frame

12, 24, and 36 weeks

Title

Myopia progression and axial elongation

Description

Percent reductions of myopia progression and axial elongation

Time Frame

during 48 weeks

Title

Self-assessment by questionnaire 1

Description

Analysis of subject self-assessment

Time Frame

during 48 weeks

Title

Self-assessment by questionnaire 2

Description

Average wearing hours across the study period

Time Frame

during 48 weeks

Title

Self-assessment by questionnaire 3

Description

Reasons and rate for discontinued wear during the study period

Time Frame

during 48 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Years

Maximum Age & Unit of Time

15 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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 Surgically altered eyes (e.g. corneal or refractive surgery, not including stye removal surgery) Receiving any medication for long-term use which may interfere with contact lens wearing, tear film production, pupil size, accommodation or refractive state, such as nasal decongestants (e.g. pseudoephedrine, phenylephrine), antihistamines (e.g. chlorpheniramine, diphenhydramine), Prednisolone or Ritalin (methyphenidate)

Overall Study Officials: