Crossover evaluation of Clinitas Soothe eye drops in symptomatic soft contact lens wearers (Part 2)

CooperVision, Inc. (USA)0 个研究点目标入组 30 人开始时间: 2019年3月1日最近更新: 2019年4月1日

试验速览

暂无简介。

•1. =18 years of age
•2. Adapted and current symptomatic soft CL wearers (i.e. >1 month of wear)
•3. Spherical spectacle prescription between +6.00 and -10.00D (inclusive)
•4. Correctable to 6/12 (20/40) or better in each eye
•5. Require visual correction in both eyes (monovision and multifocal allowed but no monofit)
•6. Have normal eyes with no evidence of any ocular abnormality or disease.

•1. Previously shown sensitivity to any of the study solutions’ components.
•2. Any systemic or ocular disease or allergies affecting ocular health.
•3. Using systemic or topical medications that will, in the investigator’s opinion, affect ocular physiology or lens performance.
•4. Clinically significant (>Grade 3) corneal stromal edema, corneal vascularisation, tarsal abnormalities, bulbar hyperemia, limbal hyperemia, or any other abnormality of the cornea that would contraindicate contact lens wear.
•5. Any corneal infiltrates or any corneal scarring or neovascularization within the central 5mm of the cornea.
•6. Keratoconus or other corneal irregularity.
•7. Aphakia or amblyopia.
•8. Has diabetes.
•9. Known/reported infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g., HIV).
•10. History of chronic eye disease (e.g. glaucoma or ARMD).
•11. Pregnant or lactating or planning a pregnancy at the time of enrolment.
•12. Participation in a concurrent clinical trial or any clinical trial (other than CDRP-402 Part 1) in the last 14 days

发起方

CooperVision, Inc. (USA)