Myopia
Conditions
Brief summary
This was a prospective, randomized, open label, parallel, active-controlled clinical study to assess the safety and efficacy of Silicone Color Contact Lens for vision correction.
Interventions
DEVICEsoft contact lens
Vision Correction
Sponsors
Yung Sheng Optical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 25 Years
Healthy volunteers
No
Inclusion criteria
1. Age from 20 to 65. 2. Subject with -1.00 to -10.00 D myopia, less than 1.00 D astigmatism. 3. Subjects must be correctable through spherocylindrical refraction and with soft contact lenses to 0 Log MAR (distance) or better in each eye. 4. Willing to comply with all study procedures and be available for the study duration. 5. Provide signed and dated informed consent form.
Exclusion criteria
1. Subjects have a history of allergies that contraindicate contact lens wear. 2. Subjects have other active ocular or systemic diseases such as, but not limited to anterior uveitis (past or present), glaucoma, Sjögren's syndrome, lupus erythematosus, sclerodermas, keratoconus or diabetes. 3. Subjects have medications that would contraindicate contact lens wear. 4. Currently pregnant (to the best of the subject's knowledge), is lactating or is planning a pregnancy within the next 3 months. 5. Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements. 6. Any active participation in any contact lens or lens care product clinical trial within seven days prior to this study. 7. The presence of clinically significant (grade 3 or 4) anterior segment abnormalities; inflammations such as iritis; or any infection of the eye, lids, or associated structures. 8. Subject has a known history of corneal hypoesthesia (reduced corneal sensitivity), corneal ulcer, corneal infiltrates or fungal infections. 9. Subject has a history of papillary conjunctivitis that has interfered with contact lens wear. 10. Subject has a history of herpetic keratitis retinal detachment or irregular cornea. 11. Subject has a history of recurrent eye or eyelid infections, adverse effects associated with your contact lens wear, intolerance or unusual response to your contact lens wear. 12. The subject has over grade II corneal and conjunctival staining (Oxford scheme) if who has a history of dry eye. 13. Subject had any corneal surgery (e.g., refractive surgery).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The effectiveness of corrected visual acuity | 3 Months | The primary effectiveness endpoint of the study was the comparison of the mean change in logMAR visual acuity (VA) of the subject's worse eye, from baseline (Day 1) to the final visit (3-month), between the groups wearing test lenses and control lenses. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness of corrected visual acuity | 1 Week | The secondary effectiveness endpoint involves comparing the mean difference in LogMAR visual acuity (VA) for each eye-both eyes of each subject-between the test lens and the control lens at one week. |
Countries
Taiwan
Outcome results
None listed