Status:
COMPLETED
A Study to Evaluate the Safety and Efficacy of Eye Secret UV Aspheric Silicone Soft (Hydrophilic) 1Day Color Contact Lens
Lead Sponsor:
Yung Sheng Optical Co., Ltd.
Conditions:
Myopia
Eligibility:
All Genders
20-25 years
Phase:
NA
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.
Eligibility Criteria
Inclusion
- Age from 20 to 65.
- Subject with -1.00 to -10.00 D myopia, less than 1.00 D astigmatism.
- Subjects must be correctable through spherocylindrical refraction and with soft contact lenses to 0 Log MAR (distance) or better in each eye.
- Willing to comply with all study procedures and be available for the study duration.
- Provide signed and dated informed consent form.
Exclusion
- Subjects have a history of allergies that contraindicate contact lens wear.
- 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.
- Subjects have medications that would contraindicate contact lens wear.
- Currently pregnant (to the best of the subject's knowledge), is lactating or is planning a pregnancy within the next 3 months.
- Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
- Any active participation in any contact lens or lens care product clinical trial within seven days prior to this study.
- 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.
- Subject has a known history of corneal hypoesthesia (reduced corneal sensitivity), corneal ulcer, corneal infiltrates or fungal infections.
- Subject has a history of papillary conjunctivitis that has interfered with contact lens wear.
- Subject has a history of herpetic keratitis retinal detachment or irregular cornea.
- 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.
- The subject has over grade II corneal and conjunctival staining (Oxford scheme) if who has a history of dry eye.
- Subject had any corneal surgery (e.g., refractive surgery).
Key Trial Info
Start Date :
February 13 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2024
Estimated Enrollment :
131 Patients enrolled
Trial Details
Trial ID
NCT06527586
Start Date
February 13 2023
End Date
November 30 2024
Last Update
January 24 2025
Active Locations (3)
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1
National Taiwan University Hospital
Taipei, Taiwan
2
Tri-Service General Hospital
Taipei, Taiwan
3
Linkou-Chang Gung Memorial Hospital
Taoyuan District, Taiwan