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

Not Applicable

Completed

• Conditions: Myopia
• Interventions: Device: soft contact lens

• Registration Number: NCT06527586
• Lead Sponsor: Yung Sheng Optical Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-02-13
• Study First Submitted: 2024-07-25
• Study First Submitted QC: 2024-07-25
• Study First Posted: 2024-07-30
• Primary Completion: 2024-11-30
• Study Completion: 2024-11-30
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-21
• Last Update Posted: 2025-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 131

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Si-Hy soft contact lens	soft contact lens	-
Si-Hy (Otufilcon A)	soft contact lens	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (3)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan

Tri-Service General Hospital; 🇨🇳 Taipei, Taiwan

Linkou-Chang Gung Memorial Hospital; 🇨🇳 Taoyuan, Taiwan