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

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.

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Device: soft contact lens

• Study Type: Interventional
• Enrollment (Actual): 131
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Tri-Service General Hospital
  • Taipei, Taiwan
    • National Taiwan University Hospital
  • Taoyuan, Taiwan
    • Linkou-Chang Gung Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Si-Hy (Otufilcon A)	Device: soft contact lens; Vision Correction
Active Comparator: Si-Hy soft contact lens	Device: soft contact lens; Vision Correction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The effectiveness of corrected visual acuity	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.	3 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effectiveness of corrected visual acuity	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.	1 Week

Collaborators and Investigators

• Sponsor: Yung Sheng Optical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2023
• Primary Completion (Actual): November 30, 2024
• Study Completion (Actual): November 30, 2024

Study Registration Dates

• First Submitted: July 25, 2024
• First Submitted That Met QC Criteria: July 25, 2024
• First Posted (Actual): July 30, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 21, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: SUV-01V1.0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No