Tear component uptake by contact lenses: symptomatic vs asymptomatic wearers

CooperVision Inc. (USA)0 个研究点目标入组 50 人开始时间: 2017年10月6日最近更新: 2019年10月7日

适应症

试验速览

暂无简介。

•1. At least 18 years old
•2. Have read and understood the Participant Information Sheet
•3. Have read, signed and dated the Informed Consent
•4. Current spherical daily contact lens wearer
•5. Spectacle refraction: Distance: Sphere: -6.00D to + 4.00D; Astigmatism: 0.00D to -0.75D
•6. Best corrected visual acuity of at least 20/30 in each eye
•7. Symptomatic wearers (test group):
•7.1. At least three hours difference between daily wearing time and comfortable wearing time
•7.2. Classified as symptomatic as per study criteria
•8. Asymptomatic wearers (control group):
•8.1. At most two hours difference between daily wearing time and comfortable wearing time
•8.2. Classified as asymptomatic as per study criteria
•9. Have normal eyes with the exception of the need for visual correction
•10. 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. Use of systemic or ocular medications for which contact lens wear could be contraindicates as determined by the investigator
•3. Monocular participants (only one eye with functional vision) or participants fit with only one lens
•4. Any moderate or severe ocular condition observed during the slit-lamp examination at the enrolment visit
•5. History of herpetic keratitis, ocular surgery or irregular cornea
•6. Known pregnancy or lactation during the study period
•7. Enrolment of the investigator or his/her staff, family members of the investigator, family members of the investigator’s staff, or individuals living in the households of these individuals
•8. Participation in any clinical trial within 30 days of the enrolment visit

发起方

CooperVision Inc. (USA)