Status:
COMPLETED
To Evaluate the Efficacy and Safety of Multifocal Soft Contact Lens in Myopia Control
Lead Sponsor:
Largan Medical Co., Ltd.
Collaborating Sponsors:
National Taiwan University Hospital
Chang Gung Memorial Hospital
Conditions:
Myopia
Eligibility:
All Genders
6-15 years
Phase:
NA
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 pla...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
May 2 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 5 2020
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT03413085
Start Date
May 2 2018
End Date
March 5 2020
Last Update
March 12 2020
Active Locations (3)
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1
Tzu-Hsun Tsai M.D.
Taipei, Taiwan, 100
2
Ken-Kuo Lin M.D.
Taipei, Taiwan, 105
3
Jiahn-Shing Lee M.D.
Taoyuan District, Taiwan, 333