Skip to main content
OpenTrials
Completed

NCT Number: NCT06716385

A Clinical Trial to Evaluate the Vision Correction Safety and Efficacy of MSiHy 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 "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)".

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Myopia Eye Diseases Refractive Errors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MayKay Memorial Hospital, Taipei, Taiwan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • 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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Visual Correction

    Time frame: 1 week, 2 week, 1 month and 2 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.

  2. Change in refraction

    Time frame: 1 week, 2 week, 1 month, 2 months and 3 months

    the sphere and cylinder power of subjective refraction

Sponsors and collaborators

Lead sponsor

Visco Vision Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 4, 2024
Registry last updated
Oct 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.