Clinical trial NCT03413085: 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
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Keywords: Myopia control
Lead sponsor: Largan Medical Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: National Taiwan University Hospital
name: Chang Gung Memorial Hospital
First posted: 2018-01-29
Enrollment: 59
Sex: ALL
Minimum age (years): 6
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Paired-eye comparison
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Objective cycloplegic refractive error
timeFrame: 48 weeks
measure: Axial length
timeFrame: 48 weeks
Secondary outcomes:
measure: Cycloplegic refractive error
timeFrame: 12, 24, and 36 weeks
measure: Axial length
timeFrame: 12, 24, and 36 weeks
measure: Myopia progression and axial elongation
timeFrame: during 48 weeks
measure: Self-assessment by questionnaire 1
timeFrame: during 48 weeks
measure: Self-assessment by questionnaire 2
timeFrame: during 48 weeks
measure: Self-assessment by questionnaire 3
timeFrame: during 48 weeks
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Tzu-Hsun Tsai M.D.
city: Taipei
country: Taiwan
facility: Ken-Kuo Lin M.D.
city: Taoyuan
country: Taiwan
facility: Jiahn-Shing Lee M.D.
Study officials:
affiliation: National Taiwan University Hospital
name: Tzu-Hsun Tsai, M.D.
role: STUDY_CHAIR
affiliation: National Taiwan University Hospital
name: Tzu-Hsun Tsai, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: National Taiwan University Hospital
name: Chao-Wen Lin, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Taipei Chang Gung Memorial Hospital
name: Ken-Kuo Lin, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Chang Gung Memorial Hospital
name: Jiahn-Shing Lee, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Chang Gung Memorial Hospital
name: Chiun-Ho Hou, M.D.
role: PRINCIPAL_INVESTIGATOR
References: