A Prospective, Randomization, Double-blind Study to Evaluate the Efficacy and Safety of Multifocal Soft Contact Lens in Myopia Control
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Myopia
- Sponsor
- Largan Medical Co., Ltd.
- Enrollment
- 59
- Locations
- 3
- Primary Endpoint
- Objective cycloplegic refractive error
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
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:
- •Severe strabismus at investigator's discretion
- •Pathologically dry eye
- •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
Outcomes
Primary Outcomes
Objective cycloplegic refractive error
Time Frame: 48 weeks
Changes in objective cycloplegic refractive error between the two eyes in 48 weeks
Axial length
Time Frame: 48 weeks
Changes in axial length between the two eyes in 48 weeks
Secondary Outcomes
- 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)
- Self-assessment by questionnaire 3(during 48 weeks)