Visual performance and visual satisfaction measurement with multifocal contact lens combinations

CooperVision Inc.0 个研究点目标入组 100 人开始时间: 2016年8月5日最近更新: 2019年10月7日

适应症

试验速览

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•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. Current spectacle or soft contact lens wearer
•5. Spectacle refraction:
•Distance: Sphere: -6.00D to +4.00D; Astigmatism: 0.00D to -0.75D
•Near Addition: Group 1 (Phase 1) - +1.00 to +1.50D; Group 2 (Phase 2) – Subgroup A +1.75 to +2.00D; Subgroup B +2.25 to +2.50D
•6. Best corrected visual acuity in each eye of at least 20/25
•7. Have normal eyes with the exception of the need for visual correction
•8. Be willing and able to adhere to the instructions set in the clinical protocol and maintain the appointment schedule

•To be eligible as a participant, each candidate shall be free of any ocular or medical condition that may affect the results of this study.
•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 contact 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

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