MyopiaNCT06716385
A Clinical Trial to Evaluate the Vision Correction Safety and Efficacy of MSiHy Silicone Hydrogel Soft Contact Lens
A study testing MSiHy Silicone Hydrogel Soft Contact Lens and Monthly Silicone Hydrogel Contact Lenses (oA) in people with Myopia and Refractive Errors, run by Visco Vision Inc. at 3 sites in Taiwan.
Trial 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". Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myopia, Refractive Errors
- What is being tested?
- MSiHy Silicone Hydrogel Soft Contact Lens and Monthly Silicone Hydrogel Contact Lenses (oA)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 3 sitesTaiwan
- Study dates
- 9 Oct 2024to 7 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 13Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
Taiwan3 sites
MayKay Memorial Hospital
Taipei, 10449
Tri-Service General Hospital
Taipei, 114202
Chang Gung Memorial Hospital, Linkou
Taoyuan
About this study
Official 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
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
- Being tested
- MSiHy Silicone Hydrogel Soft Contact Lens, Monthly Silicone Hydrogel Contact Lenses (oA)
- Keywords
- Contact lens
- Medical subject headings
- Myopia, Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MSiHy Silicone Hydrogel Soft Contact LensDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| MSiHy Silicone Hydrogel Soft Contact Lens | Experimental | New Monthly disposable contact lenses Receives: Device: MSiHy Silicone Hydrogel Soft Contact Lens |
| Monthly Silicone Hydrogel Contact Lenses (oA) | Active comparator | Monthly disposable contact lens products already on the market Receives: Device: Monthly Silicone Hydrogel Contact Lenses (oA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (2)
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.
Measured: 1 week, 2 week, 1 month and 2 months
Change in refraction
the sphere and cylinder power of subjective refraction
Measured: 1 week, 2 week, 1 month, 2 months and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2024
- Study start9 Oct 2024
- Primary completion7 Aug 2025
- Study completion7 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Visco Vision Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06716385
- Sponsor's protocol ID
- 0474TC01
- Status last verified
- Sep 2025
- First submitted
- 28 Aug 2024
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06716385
- Acronym / sponsor ID
- 0474TC01
- Conditions
- Myopia, Refractive Errors
- Keywords
- Contact lens
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Visco Vision Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Oct 2024 (actual)
- Primary completion
- 7 Aug 2025 (actual)
- Study completion
- 7 Aug 2025 (actual)
- First posted
- 4 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)".
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MSiHy Silicone Hydrogel Soft Contact Lens | Experimental | Device: MSiHy Silicone Hydrogel Soft Contact LensNew Monthly disposable contact lenses |
| Monthly Silicone Hydrogel Contact Lenses (oA) | Active comparator | Device: Monthly Silicone Hydrogel Contact Lenses (oA)Monthly disposable contact lens products already on the market |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MSiHy Silicone Hydrogel Soft Contact LensThe daily wear, monthly disposable soft contact lens for the correction of myopia and hyperopia in person with non-diseased eyes. | Device | MSiHy Silicone Hydrogel Soft Contact Lens |
| Monthly Silicone Hydrogel Contact Lenses (oA)The daily wear, monthly disposable soft contact lens for the correction of myopia and hyperopia in person with non-diseased eyes. | Device | Monthly Silicone Hydrogel Contact Lenses (oA) |
Primary outcome
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.
2 secondary outcomes
Visual Correction
Time frame: 1 week, 2 week, 1 month and 2 months
Change in refraction
Time frame: 1 week, 2 week, 1 month, 2 months and 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MSiHy Silicone Hydrogel Soft Contact Lens and Monthly Silicone Hydrogel Contact Lenses (oA) in people with Myopia and Refractive Errors, run by Visco Vision Inc. at 3 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Correction (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2025.