Clinical validation multisite study of CV multifocal contact lenses

CooperVision Inc. (USA)0 个研究点目标入组 150 人开始时间: 2019年1月24日最近更新: 2020年11月2日

适应症

试验速览

暂无简介。

•There are no requirements as to participant race, gender or occupation. In order to be enrolled, each participant shall meet the following criteria:
•1. At least 40 years old;
•2. Have read and understood the Participant Information Sheet
•3. Have read, signed and dated the Informed Consent
•4. Best corrected visual acuity of at least 20/25 in each eye
•5. Have normal eyes with the exception of the need for visual correction
•6. Current multifocal contact lens wearer
•7. Spectacle refraction:
•Distance: Sphere: -6.00D to + 4.00D
•Astigmatism: 0.00D to -0.75D
•Near Addition: +0.75D to +2.50D in three groups:
•Emerging Presbyopes:+0.75D to +1.25D
•Established Presbyopes: +1.50D and +1.75D
•Advanced presbyopes:+2.00D to +2.50D
•8. Be willing and able to adhere to the instructions set in the clinical protocol and maintain the appointment schedule

•The following are specific criteria that exclude a candidate from enrolment in this study:
•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 contraindicated 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

发起方

CooperVision Inc. (USA)