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

Myopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03413085
• Other study ID #: LMO00-CL-DM-01
• Status: Completed
• Phase: N/A
• Start date: May 2, 2018
• Est. completion date: March 5, 2020

Study information

• Verified date: March 2020
• Source: Largan Medical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: March 5, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 15 Years

Eligibility

Inclusion Criteria:

1. Both genders aged between 6 and 15 years

2. Spherical equivalent refractive error between -1.00D and -10.00D

3. Visual acuity with contact lens of 20/25 or better in each eye

4. Astigmatism less than or equal to 1.50D

5. Anisometropia less than or equal to 1.00D

6. Agree to wear assigned contact lens and able to comply with the study protocol

7. Subjects and/or their legal representatives agree to sign informed consent form

Exclusion Criteria:

1. 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

2. 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

3. 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

4. Surgically altered eyes (e.g. corneal or refractive surgery, not including stye removal surgery)

5. 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)

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• soft contact lens
Group A Group B

Locations

Country	Name	City	State
Taiwan	Ken-Kuo Lin M.D.	Taipei
Taiwan	Tzu-Hsun Tsai M.D.	Taipei
Taiwan	Jiahn-Shing Lee M.D.	Taoyuan

Sponsors (3)

Lead Sponsor	Collaborator
Largan Medical Co., Ltd.	Chang Gung Memorial Hospital, National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective cycloplegic refractive error	Changes in objective cycloplegic refractive error between the two eyes in 48 weeks	48 weeks
Primary	Axial length	Changes in axial length between the two eyes in 48 weeks	48 weeks
Secondary	Cycloplegic refractive error	Changes in objective cycloplegic refractive error between the two eyes from baseline after treatment	12, 24, and 36 weeks
Secondary	Axial length	Changes in axial length between the two eyes from baseline after treatment	12, 24, and 36 weeks
Secondary	Myopia progression and axial elongation	Percent reductions of myopia progression and axial elongation	during 48 weeks
Secondary	Self-assessment by questionnaire 1	Analysis of subject self-assessment	during 48 weeks
Secondary	Self-assessment by questionnaire 2	Average wearing hours across the study period	during 48 weeks
Secondary	Self-assessment by questionnaire 3	Reasons and rate for discontinued wear during the study period	during 48 weeks