Loading clinical trials...

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

COMPLETEDNA

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

NCT06716372•Visco Vision Inc.

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+2 more criteria

Locations (3)

Tri-Service General Hospital

Taipei, Taiwan

Chang Gung Memorial Hospital, Taipei

Taipei, Taiwan

Chang Gung Memorial Hospital, Linkou

Taoyuan District, Taiwan

Key Dates

Start Date

October 7, 2024

Primary Completion Date

August 20, 2025

Completion Date

August 20, 2025

Last Updated

October 2, 2025

Enrollment

134

ACTUAL participants

Conditions

MyopiaRefractive Errors

Interventions

DSiHy Silicone Hydrogel Soft Contact Lens

DEVICE

Daily Silicone Hydrogel Contact Lenses (oB)

DEVICE

Cognitive Level Enhancement Through Vision Exams and Refraction

NCT05458323

Refractive Errors

View study

RECRUITINGNA

Wavefront-guided LASIK Surgery Compared to Ray Tracing-Guided LASIK Surgery

NCT07078799

MyopiaAstigmatism

View study

RECRUITING

Clinical Data Collection of Myopic Patients After PTK-PRK With CZM MEL 90 Excimer Laser

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 2, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Cognitive Level Enhancement Through Vision Exams and Refraction

Wavefront-guided LASIK Surgery Compared to Ray Tracing-Guided LASIK Surgery

Clinical Data Collection of Myopic Patients After PTK-PRK With CZM MEL 90 Excimer Laser

Atropine in the Treatment of Myopia Study in Malaysia

Clinical Study on the Effectiveness of Diverse Segments Defocus Optimization in Spectacle Lenses for Slowing Myopia Progression

China Axial Length Study