Prospective, cross-over pilot trial to assess the short-term efficacy of novel myopia management spectacle films and contact lenses when worn by children.

nthalmic Pty Ltd0 个研究点目标入组 60 人开始时间: 2023年3月24日最近更新: 2024年8月5日

适应症

试验速览

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•Aged between 7-15 years inclusive
•Have read, understood and signed informed assent
•Parents have read, understood and signed informed consent
•Adhere to study requirements, wear study products and maintain visit schedule
•Have good general health and normal ocular health
•Best-corrected high contrast visual acuity of 6/7.6 or better in each eye
•If wearing spectacle study product: Spectacle refraction of:
•-sphere component between -0.50DS and -4.00DS inclusive and spherical equivalent less than or equal to -0.75D
•-Astigmatic correction between 0DC and -1.50DC inclusive
•If wearing contact lens study product: Spectacle refraction of:
•-sphere component less than or equal to -0.50D and spherical equivalent between -0.75D and -4.00D inclusive
•-Astigmatic correction between 0DC and -1.00DC inclusive

•Current or use within 12 months of myopia management options including but not limited to
•-Bifocal/multifocal spectacles or contact lenses
•-Orthokeratology
•-Atropine/pirenzepine pharmacological agents
•If contact lenses are the chosen study product: contraindications to contact lens wear, including any pre-existing ocular irritation, injury, or condition (including infection or disease) of the cornea, conjunctiva or eyelids
•Any systemic disease that adversely affects ocular health e.g., diabetes, Graves’ disease, and auto immune diseases such as ankylosing spondylitis, multiple sclerosis, Sjogrens syndrome, and systemic lupus erythematosus.
•Use of or a need for concurrent category S3 and above ocular medication at enrolment.
•Eye surgery within 12 weeks immediately prior to enrolment for this trial.
•Keratoconus
•Manifest strabismus
•Known allergy or intolerance to ingredients in any of the clinical trial products.
•Currently enrolled in another clinical trial.

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