To Evaluate the Efficacy and Safety of Aspherical Soft Contact Lens in Myopia Control
Study Details
Study Description
Brief Summary
The objective of this study is to demonstrate that the Ticon Aspherical Daily Disposable Soft Contact Lens could retard myopia progress in youth
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
This study is designed as a prospective, multicenter, randomized, double blinded, controlled, paired-eye comparison study. At least 60 evaluable subjects with myopia progression ≧ 0.75 D in the past 12 months will be recruited from 2 study sites. The experimental soft contact lens with aspherical design (Ticon Aspherical) will be randomly assigned to either the right eye or the left eye of the subject , then the fellow eye will be assigned a control lens with a single vision distance (SVD) soft contact lens (Ticon). Both lenses will be worn at least 8 hours a day, 5 days a week for 1 year. All lenses will be replaced every day. Brief assessment of the clinical findings will be followed up for one year at 1 day, 1 week, 1, 3, 6, 9, 12 months upon allocation. The primary efficacy outcome is change in spherical equivalent refraction (SER) measured by cycloplegic autorefraction over 12 months. The secondary outcome is change in axial eye length (AXL) measured over 12 months. The secondary outcome measure is used to corroborate any changes in SER
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Ticon Aspherical Daily Disposable Soft Contact Lens The subject will be requested to wear lens 8 hours a day, 5 days a week at least. The contact lens will be worn and replaced every day. All subjects will be followed for 1 year post device allocation with a brief clinical assessment at 1 day, 1 week, 1, 3, 6, 9, 12 months. |
Device: soft contact lens
|
| Placebo Comparator: Ticon Daily Soft Contact Lens The subject will be requested to wear lens 8 hours a day, 5 days a week at least. The contact lens will be worn and replaced every day. All subjects will be followed for 1 year post device allocation with a brief clinical assessment at 1 day, 1 week, 1, 3, 6, 9, 12 months. |
Device: soft contact lens
|
Outcome Measures
Primary Outcome Measures
- Spherical Equivalent Refraction (SER) [12 months]
The change in spherical equivalent refraction (SER) measured by cycloplegic autorefraction over 12 months.
Secondary Outcome Measures
- Axial Eye Length (AXL) [12 months]
The change in axial eye length (AXL) measured over 12 months. Axial length is measured after cycloplegia using optical biometry.
Other Outcome Measures
- Primary safety Endpoints [12 months]
All dispensed eyes over all follow-up visits. Measured on a scale of 0-4 with 0=no findings and 4=severe findings. Epithelial edema, epithelial microcysts, corneal staining, limbal & bulbar injection, conjunctival abnormalities, corneal neovascularization and infiltrates will be measured.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Myopia (SE) between -1.00D to -8.00D
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Astigmatism less than or equal to 1.75D
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Myopia progression ≧0.75 D in the past 12 months
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Best Corrected Visual Acuity (BCVA): 0.9 Snellen or better
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Willingness to wear contact lens constantly
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Availability for follow-up for at least 1 year
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Parent's understanding and acceptance
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have an acceptable surrogate capable of giving legally authorized consent on behalf of the subject
Exclusion Criteria:
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Anisometropia greater than 2.00D
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Presence of ocular disease preventing wear of contact lens
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Severe ocular or systemic allergies
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Taking any medication that might have an impact on contact lens wear or that might influence the outcome of the clinical trial
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Ocular or systemic condition that might affect refractive development
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Atropine/Pirenzepine treatment for myopia control in the past 1 month
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Prior use of Ortho-K lenses
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Dry eye with Schimer Test (basal secretion test) < 5mm/5min or other physical condition that would contraindicate contact lens wear
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- APP Vision Care Inc.
- National Taiwan University Hospital
- Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Investigators
- Study Chair: Tzu-Hsun Tsai, M.D., National Taiwan University Hospital
- Principal Investigator: Elizabeth P Shen, M.D., Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
- Principal Investigator: Hsiao-Sang Chu, M.D., National Taiwan University Hospital
- Principal Investigator: Han-Chih Cheng, M.D., Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 1011128M