Validation study of the clinical acceptance and performance of Hercules soft contact lenses

CooperVision International Limited0 sites63 target enrollmentStarted: June 11, 2021Last updated: May 9, 2022

Conditions

Trial Snapshot

No summary available.

•1. Age 8 to 18 years;
•2. Current soft contact lens wearers;
•3. Spectacle refraction: -0.75 to -6.00D spherical equivalent, with cylinder = -0.75 DC and maximum anisometropia of <1.00D;
•4. Best corrected visual acuity of at least 20/25 in each eye;
•5. Parents/guardians and participant have read and understood the Participant Information Sheet;
•6. Parents/guardians and participant have read, signed and dated the Informed Consent;
•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.

•1. Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear;
•2. Newly prescribed use of some 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. Subjects with slit lamp findings greater than grade 1 (e.g. edema, infiltrates, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival, anterior segment inflammation) as per ISO 11980, any previous history or signs of a contact lens related corneal inflammatory event (past corneal ulcers), or any other ocular abnormality that may contraindicate contact lens wear at the enrolment visit;
•5. History of herpetic keratitis, ocular surgery or irregular cornea;
•6. Enrolment of the family members of the investigator, family members of the investigator’s staff, or individuals living in the households of these individuals.

Sponsor