The investigation of the effect of new contact lens disinfectant solution to the symptoms of contact lens discomfort in participants who have been wearing contact lenses for at least 6 months

niversity of New South Wales0 个研究点目标入组 30 人开始时间: 2023年12月4日最近更新: 2023年12月12日

适应症

试验速览

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•Be at least 18 years of age,
•Able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent.
•Contact lens wearers who have worn lenses for at least 6 months, used contact lenses for 3 weeks before the evaluation visit and used these lenses at least four times a week. Contact lenses should have been worn on daily wear modality, where the lenses are worn for at least 6hours per day and remove the lenses before sleep.
•Willing to wear their lenses a minimum of 6 hours per day at least 5 days per week for the duration of the study (12 weeks),
•Willing to not use any rewetting eye drops for the duration of the study and to refrain from swimming, showering and/or sleeping while wearing the contact lenses for the duration of the study.
•Willing to undergo the tests outlined in the section 3 of this form.
•Experience symptoms of contact lens discomfort (CLD), defined as CLDEQ-8 Questionnaire score more than 13.
•Have health and ocular health, defined as no fluorescein after a single instillation of non-preserved fluorescein solution followed by examination 1 minute after instillation, considering minimal staining of grade 1 as normal in contact lens wearers.
•Normal corrected vision, defined as a minimum of 20/40 best corrected visual acuity in each eye.

•Any active corneal infection, allergies, and Acute or sub-acute inflammation of the anterior chamber.
•Severe insufficiency of lacrimal secretion (dry eye, less than or equal to 10mm for Phenol red thread test at Baseline).
•Any systemic disease or medication use that may affect the eye such as diabetes and use of antihistamines,
•People who have undergone corneal refractive surgery and neurological disorder such as epilepsy.
•Be pregnant, planning to become pregnant during the 6 weeks of the study or be lactating (any participant that does become pregnant during the study should inform the study personnel immediately so that they can be withdrawn from the study since the increased level of hormones can impact ocular comfort during lens wear).

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