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

Last updated: September 26, 2025
Sponsor: Visco Vision Inc.
Overall Status: Completed

Phase

N/A

Condition

Eye Disorders/infections

Myopia

Treatment

DSiHy Silicone Hydrogel Soft Contact Lens

Daily Silicone Hydrogel Contact Lenses (oB)

Clinical Study ID

NCT06716372
0474TC02
  • Ages > 18
  • All Genders

Study Summary

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)".

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Must be 18 years of age inclusive

  2. Beside myopia and astigmatism, subjects with normal eyes and are not using anyocular 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 onmanifest 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 formbefore starting the clinical study

Exclusion

Exclusion Criteria:

  1. Anterior segment infection, inflammation or abnormality

  2. Any active ocular disease that would affect contact lens wear or vision (such asacute and subacute inflammation of the anterior chamber of the eye, eye infection,uveitis, serious palpebral abnormality, corneal hypoesthesia, corneal epitheliumabrasion, dry eye and tear duct defection, ocular allergies, highly suspectedglaucoma) upon evaluation by the investigators or slit lamp findings

  3. Currently using systemic or ocular medications that would contraindicate contactlens wear (such as glaucoma eye drops, steroid anti-inflammatory drops, eyeointments, 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 gradingstandards 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 trialswithin 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 knownallergy 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 Design

Total Participants: 134
Treatment Group(s): 2
Primary Treatment: DSiHy Silicone Hydrogel Soft Contact Lens
Phase:
Study Start date:
October 07, 2024
Estimated Completion Date:
August 20, 2025

Connect with a study center

  • Chang Gung Memorial Hospital, Taipei

    Taipei,
    Taiwan

    Site Not Available

  • Tri-Service General Hospital

    Taipei, 114202
    Taiwan

    Active - Recruiting

  • Chang Gung Memorial Hospital, Taipei

    Taipei 1668341,
    Taiwan

    Site Not Available

  • Tri-Service General Hospital

    Taipei 1668341, 114202
    Taiwan

    Site Not Available

  • Chang Gung Memorial Hospital, Linkou

    Taoyuan,
    Taiwan

    Site Not Available

  • Chang Gung Memorial Hospital, Linkou

    Taoyuan District 1667905,
    Taiwan

    Site Not Available

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