A Clinical Trial to Evaluate the Vision Correction Safety and Efficacy of MSiHy Silicone Hydrogel Soft Contact Lens
NCT ID: NCT06716385
Last Updated: 2025-10-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
134 participants
INTERVENTIONAL
2024-10-09
2025-08-07
Brief Summary
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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)".
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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MSiHy Silicone Hydrogel Soft Contact Lens
New Monthly disposable contact lenses
MSiHy Silicone Hydrogel Soft Contact Lens
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)
Monthly disposable contact lens products already on the market
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.
Interventions
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MSiHy Silicone Hydrogel Soft Contact Lens
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)
The daily wear, monthly disposable soft contact lens for the correction of myopia and hyperopia in person with non-diseased eyes.
Eligibility Criteria
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Inclusion Criteria
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
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
11. Allergy to any contact lens care product ingredient
12. Corrected visual acuity in either eye does not reach 1.0 when wearing the trial lens
13. Subjects who are judged by the investigators as unsuitable for the study
18 Years
ALL
No
Sponsors
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Visco Vision Inc.
INDUSTRY
Responsible Party
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Locations
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MayKay Memorial Hospital
Taipei, , Taiwan
Tri-Service General Hospital
Taipei, , Taiwan
Chang Gung Memorial Hospital, Linkou
Taoyuan District, , Taiwan
Countries
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Other Identifiers
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0474TC01
Identifier Type: -
Identifier Source: org_study_id
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