Myopia, Refractive Errors
Conditions
Keywords
Contact lens
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).
Interventions
DEVICEMSiHy 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.
DEVICEMonthly 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.
Sponsors
Visco Vision Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Must be 18 years of age inclusive 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
1. Anterior segment infection, inflammation or abnormality 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Correction | 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
| Measure | Time frame | Description |
|---|---|---|
| Visual Correction | 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. |
| Change in refraction | 1 week, 2 week, 1 month, 2 months and 3 months | the sphere and cylinder power of subjective refraction |
Countries
Taiwan
Outcome results
None listed