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

NCT06716385 | Completed

• 1 other identifier: 0474TC01
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 3

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 "MSiHy Silicone Hydrogel Soft Contact Lens". Subjects will be randomized in 1:1 ratio to wear either the investigational device "MSiHy Silicone Hydrogel Soft Contact Lens" or the control device Monthly Silicone Hydrogel Contact Lenses(oA)".

Conditions

Myopia; Refractive Errors

Keywords

Contact lens

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Visual Correction

  1 week, 2 week, 1 month and 2 months

• Change in refraction

  1 week, 2 week, 1 month, 2 months and 3 months

Study Arms (2)

MSiHy Silicone Hydrogel Soft Contact Lens

EXPERIMENTAL

New Monthly disposable contact lenses

Device: MSiHy Silicone Hydrogel Soft Contact Lens

Monthly Silicone Hydrogel Contact Lenses (oA)

ACTIVE COMPARATOR

Monthly disposable contact lens products already on the market

Device: Monthly Silicone Hydrogel Contact Lenses (oA)

Interventions

MSiHy Silicone Hydrogel Soft Contact Lens DEVICE

The daily wear, monthly disposable soft contact lens for the correction of myopia and hyperopia in person with non-diseased eyes.

MSiHy Silicone Hydrogel Soft Contact Lens

Monthly Silicone Hydrogel Contact Lenses (oA) DEVICE

The daily wear, monthly disposable soft contact lens for the correction of myopia and hyperopia in person with non-diseased eyes.

Monthly Silicone Hydrogel Contact Lenses (oA)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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
• Allergy to any contact lens care product ingredient
• Corrected visual acuity in either eye does not reach 1.0 when wearing the trial lens
• Subjects who are judged by the investigators as unsuitable for the study

Sponsors & Collaborators

• Visco Vision Inc.: lead

Study Sites (3)

MayKay Memorial Hospital

Taipei, 10449, Taiwan

Location

Tri-Service General Hospital

Taipei, 114202, Taiwan

Location

Chang Gung Memorial Hospital, Linkou

Taoyuan District, Taiwan

Location

MeSH Terms

Conditions

Myopia; Refractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2024
• First Posted: December 4, 2024
• Study Start: October 9, 2024
• Primary Completion: August 7, 2025
• Study Completion: August 7, 2025
• Last Updated: October 2, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TW (3)