Clinical acceptance and performance of soft contact lenses Eye Diseases
Conditions
Interventions
Randomisation is carried out by a standard computer randomisation generator software. Two soft contact lenses will be worn by each participant in a random order in turn for 1 week on a daily disposabl
Sponsors
CooperVision International Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall binocular visual performance (logMAR chart) measured after 9 - 13 days of wear | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Overall comfort on a 100-point visual analog scale measured after 9 - 13 days of wear 2. Daily wearing time in hours measured after 9 - 13 days of wear | — |
Countries
England, United Kingdom
Contacts
Public ContactDeborah Moore
Outcome results
None listed