A Study to Evaluate the Safety and Efficacy of Eye Secret UV Aspheric Silicone Soft (Hydrophilic) 1Day Color Contact Lens

Yung Sheng Optical Co., Ltd.3 sites in 1 country131 target enrollmentFebruary 13, 2023

ConditionsMyopia

Overview

Phase: N/A
Intervention: Not specified
Conditions: Myopia
Sponsor: Yung Sheng Optical Co., Ltd.
Enrollment: 131
Locations: 3
Primary Endpoint: The effectiveness of corrected visual acuity
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 13, 2023

End Date

November 30, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Yung Sheng Optical Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age from 20 to
•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 Criteria

•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.

Outcomes

Primary Outcomes

The effectiveness of corrected visual acuity

Time Frame: 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.