To Evaluate the Effectiveness of New Specially Designed Fitlens Soft Lens.

Overview

Myopia is a common disorder, affecting approximately one-third of the US population and over 90% of the population in some East Asian countries. High amounts of myopia are associated with an increased risk of sight-threatening problems, such as retinal detachment, choroidal degeneration, cataracts, and glaucoma. Slowing the progression of myopia could potentially benefit millions of children. To date, few strategies used for myopia control have proven to be effective. Currently, there are four categories of myopia control treatments: atropine eye drops, multifocal contact lenses, multifocal eyeglasses, and orthokeratology (ortho-k). None of these modalities are US Food and Drug Administration-approved to slow myopia progression, they have been shown to slow the progression by approximately 50% with few risks. Both orthokeratology and soft bifocal contact lenses have shown to slow myopia progression by slightly less than 50% in most studies. The Myolens progressive front soft contact lens is designed to slow down myopia progression in children, The Myolens lens is an aspheric design with a spherical back surface that provides clear vision, with a uniform round edge for excellent fit and optimum comfort. The Myolens-CN is designed with a central for the near optics, while the Myolens-CF with a central for the distance optics, which progressively changes to far area and within a defined optical zone area while considering the movement up-down of the lens on the cornea. The thought behind the design is that the center of the lens will not provide a full optical correction. In the suggested study, both Myolens modalities CN and CF will be investigated in compare to the current approved treatment - MiSight.

Study Procedures: Screening period (up to 3 weeks prior to enrollment) 1. Obtaining inform consent. 2. Obtaining subject's relevant medical history and concomitant therapy - concurrent active medical conditions with emphasis on ocular and systemic diseases. 3. Performance of ophthalmic examination (slit lamp), IOP, BCVA, cycloplegia refractive, axial length measurement, spherical equivalent calculation, Cover test, fundus photography and corneal topography. 4. Confirmatiom of subject's eligiblity 5. Subject's randomization to either of the study arms 6. Personal fitting of the Myolens-CN/CF or MiSight as per randomization Week 1 Day 1 (±3 days) 1. Performance of ophthalmic examination (slit lamp), BCVA, cycloplegia refractive, axial length measurement, spherical equivalent calculation. 2. Subject will be instructed regarding the use and handling of the lens both written and verbally. 3. AE and concomitant therapy monitoring Treatment period (36 months) 1. The lenses will be worn by the subject every day, for a maximum of 14 hours per day. 2. For the subjects allocated to either CN or CF arm, lenses will be replaced every 3 months. 3. At M36 visit lenses will be removed. 4. Each follow up visit will include: ophthalmic examination (slit lamp), BCVA test , axial length measurement, refractive assessment and spherical equivalence calculation, subject diary review, AE monitoring and changes in concomitant medications. Follow up period (4 weeks) End of study (EOS) visit will be conducted 4 weeks after EOT. Completion of the study will be considered as the completion of visit 36M which will the EOT visit for the subject and 4 weeks follow up. In case of early termination, EOS will be conducted upon time of termination (UNS). EOS visit procedures are equal to 36M visit procedures.