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

NCT06527586 | Completed

• 1 other identifier: SUV-01V1.0
• Study Type: interventional
• Target: 131
• Locations: 1 country
• Sites: 3

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Effectiveness of corrected visual acuity

  1 Week

Study Arms (2)

Si-Hy (Otufilcon A)

EXPERIMENTAL

Device: soft contact lens

Si-Hy soft contact lens

ACTIVE COMPARATOR

Device: soft contact lens

Interventions

soft contact lens DEVICE

Vision Correction

Si-Hy (Otufilcon A); Si-Hy soft contact lens

Eligibility Criteria

• Age: 20 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Yung Sheng Optical Co., Ltd.: lead

Study Sites (3)

National Taiwan University Hospital

Taipei, Taiwan

Location

Tri-Service General Hospital

Taipei, Taiwan

Location

Linkou-Chang Gung Memorial Hospital

Taoyuan District, Taiwan

Location

MeSH Terms

Conditions

Myopia

Interventions

Contact Lenses, Hydrophilic

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Intervention Hierarchy (Ancestors)

Contact Lenses; Lenses; Optical Devices; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2024
• First Posted: July 30, 2024
• Study Start: February 13, 2023
• Primary Completion: November 30, 2024
• Study Completion: November 30, 2024
• Last Updated: January 24, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TW (3)