Phase
Condition
Myopia
Eye Disorders/infections
Treatment
CooperVision MiSight (omafilcon A/60%) Myopia Control one day Soft Contact Lens
Bausch + Lomb (kalifilcon A) Myopia Control Soft (Hydrophilic)
Clinical Study ID
Ages 8-12 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Male or female aged 8 to 12 years plus 11 months old on the date the Informed Assentand Parental or Guardian Informed Consent are signed and have capacity to providevoluntary informed consent.
Subject must meet the following determined by cycloplegic subjective refraction inboth eyes at screening:
Spherical Equivalent Refractive Error (SERE): between -0.75 D and -4.00 D,inclusive.
Astigmatism: ≤ -0.75 D. c. Anisometropia: < 1.00 D.
Subject must be myopic and require lens correction from -0.75 D to -4.00 D, atscreening, in each eye.
Subject must have distance best-spectacle corrected visual acuity (BSCVA) bynon-cycloplegic manifest refraction of +0.04 logMAR (20/20 Snellen equivalent) orbetter in each eye.
Subject and Parent or Guardian must be willing to participate in either the test orthe comparator assignment.
Subject agrees to wear the assigned contact lenses for a minimum of 10 hours perday, at least 6 days per week, for the duration of the 24-month study.
Subject must have wearable and visually functioning eyeglasses.
Subject must be in good general health according to their and parent's or guardian'sknowledge
Exclusion
Exclusion Criteria:
Subject has previously worn, or currently wears rigid gas permeable contact lenses,including orthokeratology lenses.
Current or prior use of bifocals, progressive addition lenses, multifocal softcontact lenses, atropine, pirenzepine or ANY other myopia control treatment.
Subject appears to exhibit poor personal hygiene (that in the Investigator's opinionmight prevent safe contact lens wear).
Per oral inquiry from parents/guardian, the subject was born earlier than 30 weeksor weighed less than 1,500 g at birth.
Prior strabismus, intraocular, or refractive surgery.
Subject using any systemic or local eye medication that interfere with the wearingof corneal contact lenses, pupil size, adjustment or refractive status, or requirethe removal of lenses during the day".
A known allergy to fluorescein, benoxinate, proparacaine, or cyclopentolate.
A history of corneal hypoesthesia (reduced corneal sensitivity), corneal ulcer,corneal infiltrates, ocular viral or fungal infections or other recurrent ocularinfections.
Strabismus by cover test at far (4 m) or near (40 cm) wearing distance correction.
Known ocular or systemic disease such as, but not limited to: anterior uveitis oriritis, episcleritis or scleritis, glaucoma, Sjögren's syndrome, lupuserythematosus, scleroderma, or diabetes.
At the discretion of the Investigator, any ocular, systemic or neuro developmentalconditions that could influence refractive development such as, but not limited to:persistent pupillary membrane, vitreous hemorrhage, cataract, corneal scarring,ptosis, eyelid hemangiomas, Marfan's syndrome, Down syndrome, Ehlers-Danlossyndrome, Stickler syndrome, ocular albinism, retinopathy of prematurity. Subjectswith trichiasis, that in the Investigator's judgement does not interfere withcontact lens wear, are eligible for this study.
Keratoconus or an irregular cornea.
Subjects with any Grade 2 or greater finding during the slit lamp examination, orsubjects with any scar or neovascularization within the central 6 mm of the cornea,or subjects with corneal infiltrates, of ANY GRADE.
Subjects with any "present" finding during the slit lamp examination (biomicroscopy)that, in the investigator's judgment, interferes with contact lens wear. Subjectswith minor peripheral corneal scarring (that does not extend into the central area),that in the Investigator's judgment does not interfere with contact lens wear, areeligible for this study.
The Investigator for any reason considers that it is not in the best interest of theSubject to participate in the study.
Subjects participating in any drug clinical investigation within 4 weeks or deviceclinical investigation within 2 weeks prior to entry into this study (Screening/Dispensing Visit) and/or planning to do so during the period of studyparticipation.
Immediate family or close relative is a member of site study team members
Study Design
Study Description
Connect with a study center
Site 105
Beijing, Beijing 100044
ChinaSite Not Available
Site 107
Dongcheng, Beijing 100730
ChinaSite Not Available
Site 109
Xiamen, Fujian 361004
ChinaSite Not Available
Site 111
Haikou, Hainan 570311
ChinaSite Not Available
Site 110
Wuhan, Hubei 430012
ChinaSite Not Available
Site 102
Shanghai, Shanghai 200433
ChinaSite Not Available
Site 106
Taiyuan, Shanxi 030072
ChinaSite Not Available
Site 108
Shenzhen, Shenzhen 518040
ChinaSite Not Available
Site 103
Chengdu, Sichaun Province 610044
ChinaSite Not Available
Site 104
Nankai, Tianjin 300392
ChinaSite Not Available
Site 101
Wenzhou, Zhejiang 325027
ChinaActive - Recruiting
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