To Evaluate the Effectiveness of New Specially Designed Fitlens Soft Lens. (NCT05433792) | Clinical Trial Compass
UnknownNot Applicable
To Evaluate the Effectiveness of New Specially Designed Fitlens Soft Lens.
Israel66 participantsStarted 2022-05-10
Plain-language summary
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.
Who can participate
Age range8 Years – 12 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Be between 8 and 12 years of age inclusive at baseline examination.
✓. The participant has been given a detailed, clear explanation concerning the study aspects and procedures.
✓. The participant's parents or legal guardian have been given a clear explanation, then read, understood, and signed the informed consent form.
✓. Willingness to adhere to protocol, agreement to maintain the visit schedule.
✓. Along with their parent or guardian, agree to maintain the visit schedule and be able to keep all appointments as specified in the study protocol for the duration of the study.
✓. Agreement to wear the assigned contact lenses for a minimum of 10 hours per day, at least 6 days per week, for the duration of the 3-year study.
✓. Subject with normal eyes who is not using any ocular medications.
✓. Possess wearable and visually functional eyeglasses.
Exclusion criteria
What they're measuring
1
Axial length change from baseline visit to 12 months visit.
Timeframe: from baseline visit to 12 months visit
2
Spherical equivalent change from baseline visit to 12 months visit.
. Subject is currently or within 30 days before this study has been an active participant in another clinical study involving an investigational treatment.
✕. Current or prior use of bifocals, progressive addition lenses, atropine, pirenzepine, or any other myopia control treatment.
✕. Birth earlier than 30 week or \<1500 g (3.3 lb) at birth.
✕. Regular use of ocular medications, artificial tears, or wetting agents.
✕. Current use of systemic medications, which may affect contact lens wear, tear film production, pupil size, accommodation, or refractive state.
✕. A known allergy to any of the Myolens components.
✕. A history of corneal hypoesthesia (reduced corneal sensitivity), corneal ulcer, corneal infiltrates, ocular viral or fungal infections, or other recurrent ocular infections.
✕. Strabismus by cover test at distance or near wearing distance correction.