Evaluation of Rexon-Eye efficacy in symptomatic contact lens wearers and dry eye sufferers

CooperVision Inc. (USA)0 个研究点目标入组 54 人开始时间: 2018年3月23日最近更新: 2020年4月27日

适应症

试验速览

暂无简介。

•Group 1: current daily disposable contact lens wearers
•1. Age 18 to 45 years
•2. Symptomatic wearers defined by a CLDEQ-8 score = 14
•3. Presence of ocular tissue anomaly and/or low tear volume:
•Group A: ocular tissue anomalies defined as bulbar conjunctival lissamine green staining Grade 2 or greater and/or
•Group B: tear volume in the lower population quartile for contact lens wearers
•4. Spectacle refraction: Sphere: -6.00D to + 4.00D, Astigmatism: 0.00D to -0.75D
•5. Best corrected visual acuity of at least 20/30 in each eye
•6. Have normal eyes with the exception of the need for visual correction
•7. Be willing and able to adhere to the instructions set in the clinical protocol and maintain the appointment schedule
•Group 2: non-contact lens wearers dry eye sufferers
•1. Age 18 to 65 years
•2. Symptomatic dry eye sufferer defined by an OSDI score = 13
•3. Presence of ocular tissue anomaly and/or low tear volume:
•Group A: ocular tissue anomalies defined as bulbar conjunctival lissamine green staining Grade 2 or greater and/or
•Group B: tear volume in the lower population quartile for non-contact lens wearers
•4. Spectacle refraction: Sphere: -6.00D to + 4.00D, Astigmatism: 0.00D to -2.50D
•5. Best corrected visual acuity of at least 20/30 in each eye
•6. Have normal eyes with the exception of the need for visual correction
•7. 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 contraindicated as determined by the investigator
•3. Use of ocular medications
•4 Monocular participants (only one eye with functional vision) or participants fit with only one contact lens
•5. Any moderate or severe ocular condition observed during the slit-lamp examination at the enrolment visit
•6. History of herpetic keratitis, ocular surgery or irregular cornea
•7. Known pregnancy or lactation during the study period
•8. 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
•9. Participation in any clinical trial within 30 days of the enrolment visit

发起方

CooperVision Inc. (USA)