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

Visco Vision Inc.3 sites in 1 country134 target enrollmentOctober 7, 2024

ConditionsMyopia Refractive Errors

Overview

Phase: N/A
Intervention: Not specified
Conditions: Myopia
Sponsor: Visco Vision Inc.
Enrollment: 134
Locations: 3
Primary Endpoint: Visual Correction
Status: Completed
Last Updated: 7 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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)".

Registry

clinicaltrials.gov

Start Date

October 7, 2024

End Date

August 20, 2025

Last Updated

7 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Visco Vision Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

•Anterior segment infection, inflammation or abnormality
•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
•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)
•History of herpetic keratitis
•History of refractive surgery, keratoconus or irregular cornea
•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)
•A pathologically dry eye (Schirmer test 1 \<5 mm)
•Have participated in any contact lens or contact lens care product clinical trials within the previous 1 month (excluding questionnaire types and specimen collection)
•Currently pregnant, lactating, or planning to be pregnant during the trial
•Have experienced discomfort when wearing silicone hydrogel contact lens, or a known allergy to hyaluronic acid and sodium alginate

Outcomes

Primary Outcomes

Visual Correction

Time Frame: 3 months

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.