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

NCT ID: NCT06527586

Last Updated: 2025-01-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 131 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-13
• Study Completion Date: 2024-11-30

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.

Conditions

Myopia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Si-Hy (Otufilcon A)

Group Type: EXPERIMENTAL

soft contact lens

Intervention Type: DEVICE

Vision Correction

Si-Hy soft contact lens

Group Type: ACTIVE_COMPARATOR

soft contact lens

Intervention Type: DEVICE

Vision Correction

Interventions

soft contact lens

Vision Correction

Intervention Type: DEVICE

Eligibility Criteria

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).

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yung Sheng Optical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

National Taiwan University Hospital

Taipei, , Taiwan

Tri-Service General Hospital

Taipei, , Taiwan

Linkou-Chang Gung Memorial Hospital

Taoyuan District, , Taiwan

Countries

Taiwan

Other Identifiers

SUV-01V1.0

Identifier Type: -

Identifier Source: org_study_id