A Clinical Trial to Evaluate the Vision Correction Safety and Efficacy of MSiHy Silicone Hydrogel… (NCT06716385) | Clinical Trial Compass
CompletedNot Applicable
A Clinical Trial to Evaluate the Vision Correction Safety and Efficacy of MSiHy Silicone Hydrogel Soft Contact Lens
Taiwan134 participantsStarted 2024-10-09
Plain-language 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)".
Who can participate
Age range18 Years
SexALL
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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 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)