A Clinical Trial to Evaluate the Vision Correction Safety and Efficacy of DSiHy Silicone Hydrogel Soft Contact Lens

A Prospective, Randomized, Double-blind, Parallel, Active-controlled Clinical Trial to Evaluate the Vision Correction Safety and Efficacy of DSiHy Silicone Hydrogel Soft Contact Lens

This is a prospective, randomized, double-blind, parallel, active-controlled, multi-center clinical study. The purpose is to evaluate the safety and effectiveness wearing "DSiHy Silicone Hydrogel Soft Contact Lens". Subjects will be randomized in 1:1 ratio to wear either the investigational device "DSiHy Silicone Hydrogel Soft Contact Lens" or the control device Daily Silicone Hydrogel Contact Lenses(oB)".

Study Overview

• Status: Completed
• Conditions: Refractive Errors; Myopia
• Intervention / Treatment: Device: DSiHy Silicone Hydrogel Soft Contact Lens; Device: Daily Silicone Hydrogel Contact Lenses (oB)

• Study Type: Interventional
• Enrollment (Actual): 134
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 114202
    • Tri-Service General Hospital
  • Taipei, Taiwan
    • Chang Gung Memorial Hospital, Taipei
  • Taoyuan District, Taiwan
    • Chang Gung Memorial Hospital, Linkou

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Must be 18 years of age inclusive
2. Beside myopia and astigmatism, subjects with normal eyes and are not using any ocular medications (excluding ocular lubricants and artificial tears)
3. Best spectacle corrected visual acuity greater than or equal to 1.0 for both eyes
4. With +8.00D ~ -12.00 D spherical component myopia, and ≤1.00 astigmatism (based on manifest refraction measurements)
5. Have worn soft contact lens for at least 2 month prior to the study
6. Willing to comply with the required wearing time
7. Agree to comply with all study procedures, sign and date the informed consent form before starting the clinical study

Exclusion Criteria:

1. Anterior segment infection, inflammation or abnormality
2. Any active ocular disease that would affect contact lens wear or vision (such as acute and subacute inflammation of the anterior chamber of the eye, eye infection, uveitis, serious palpebral abnormality, corneal hypoesthesia, corneal epithelium abrasion, dry eye and tear duct defection, ocular allergies, highly suspected glaucoma) upon evaluation by the investigators or slit lamp findings
3. Currently using systemic or ocular medications that would contraindicate contact lens wear (such as glaucoma eye drops, steroid anti-inflammatory drops, eye ointments, eye gels and other eye medicines)
4. History of herpetic keratitis
5. History of refractive surgery, keratoconus or irregular cornea
6. Slit lamp findings that are not suitable for inclusion (Details of the grading standards for each eye condition are specified in CIP section 5.7.5)
7. A pathologically dry eye (Schirmer test 1 <5 mm)
8. Have participated in any contact lens or contact lens care product clinical trials within the previous 1 month (excluding questionnaire types and specimen collection)
9. Currently pregnant, lactating, or planning to be pregnant during the trial
10. Have experienced discomfort when wearing silicone hydrogel contact lens, or a known allergy to hyaluronic acid and sodium alginate
11. Corrected visual acuity in either eye does not reach 1.0 when wearing the trial lens
12. Subjects who are judged by the investigators as unsuitable for the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DSiHy Silicone Hydrogel Soft Contact Lens; New Daily disposable contact lenses	Device: DSiHy Silicone Hydrogel Soft Contact Lens; The daily wear, daily disposable soft contact lens for the correction of myopia and hyperopia in person with non-diseased eyes.
Active Comparator: Daily Silicone Hydrogel Contact Lenses (oB); Daily disposable contact lens products already on the market	Device: Daily Silicone Hydrogel Contact Lenses (oB); The daily wear, daily disposable soft contact lens for the correction of myopia and hyperopia in person with non-diseased eyes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Correction	The effectiveness of vision correction is defined by the proportion of subjects whose contact lens corrected visual acuity in both eyes is 1.0 or greater.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Correction	The effectiveness of vision correction is defined by the proportion of subjects whose contact lens corrected visual acuity in both eyes is 1.0 or greater.	1 week, 2 week, 1 month and 2 months
Change in refraction	The sphere and cylinder power of subjective refraction	1 week, 2 week, 1 month, 2 months and 3 months

Collaborators and Investigators

• Sponsor: Visco Vision Inc.

Study record dates

Study Major Dates

• Study Start (Actual): October 7, 2024
• Primary Completion (Actual): August 20, 2025
• Study Completion (Actual): August 20, 2025

Study Registration Dates

• First Submitted: August 28, 2024
• First Submitted That Met QC Criteria: December 3, 2024
• First Posted (Actual): December 4, 2024

Study Record Updates

• Last Update Posted (Estimated): October 2, 2025
• Last Update Submitted That Met QC Criteria: September 26, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Contact lens
• Additional Relevant MeSH Terms: Eye Diseases; Myopia; Refractive Errors
• Other Study ID Numbers: 0474TC02

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