Toric contact lenses non-dispensing fitting study

CooperVision International Limited0 个研究点目标入组 25 人开始时间: 2021年11月29日最近更新: 2024年2月19日

适应症

试验速览

暂无简介。

•1. Age 8 to 15 years
•2. Current soft contact lens wearers
•3. Parent/guardian and participant have read and understood the Participant Information Sheet
•4. Parent/guardian and participant have read, signed and dated the Informed Consent and Assent (when applicable)
•5. Best corrected visual acuity of at least 20/25 in each eye
•6. Have normal eyes with the exception of the need for visual correction
•7. Spectacle refraction: -0.75 to -6.00 D Spherical equivalent, cylinder of at least -0.50 D (with at least 80% of participants with a cylinder of at least -0.75 D)
•8. Be willing and able to adhere to the instructions set in the clinical protocol and maintain the appointment schedule

•1. Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear
•2. Newly prescribed (within the past 30 days) use of some systemic medications (such as antihistamines, decongestants, diuretics, muscle relaxants, tranquilizers, stimulants, anti-depressants, anti-psychotics, oral contraceptives) or new prescription eyedrops which is not rewetting/lubricating eyedrops for which contact lens wear could be contraindicated as determined by the investigator
•3. Monocular participants (only one eye with functional vision) or participants fit with only one lens
•4. Subjects with slit-lamp findings greater than grade 1 (e.g. edema, infiltrates, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival, anterior segment inflammation) as per ISO 11980, any previous history or signs of a contact lens related corneal inflammatory event (past corneal ulcers), or any other ocular abnormality that may contraindicate contact lens wear at the enrolment visit
•5. History of herpetic keratitis, ocular surgery or irregular cornea
•6. Enrolment of the family members of the investigator, family members of the investigator’s staff, or individuals living in the households of these individuals

发起方