Crossover evaluation of two different eye drops in symptomatic soft contact lens wearers

CooperVision, Inc.0 sites20 target enrollmentJune 7, 2019

Overview

No summary available.

Registry

who.int

Start Date

June 7, 2019

End Date

April 16, 2019

Last Updated

6 years ago

Study Type

Interventional

Sex

All

Sponsor

•Subjects will be defined as symptomatic contact lens wearers if they present with at least one of the following two criteria at baseline:
•1\. Difference in reported wearing time and comfortable wearing time \>2 hours
•2\. Score \=14 by CLDEQ\-8
•All subjects must satisfy the following conditions prior to enrolling in the study:
•1\. Be \=18 years of age
•2\. Able to read, comprehend and sign an informed consent
•3\. Willing to comply with the wear and study assessment schedule
•4\. Adapted and current symptomatic soft CL wearers (i.e. \>1 month of wear)
•5\. Spherical spectacle prescription between \+6\.00 and \-10\.00D (inclusive)
•6\. Correctable to 6/12 (20/40\) or better in each eye

•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 oedema, corneal vascularisation, tarsal abnormalities, bulbar hyperaemia, limbal hyperaemia, 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\. 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)