Myopia Eye Diseases Myopia
Conditions
Interventions
Randomisation is carried out by a standard computer randomisation generator software. Three soft contact lenses (Eni Eye Q Multifocal Contact Lenses for Daily Wear XT1, XT2 and XTC) will be worn in tu
Sponsors
CooperVision (United States)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 10 to 16 years 2. Spectacle refraction: -0.75 to -6.00D spherical equivalent, maximum anisometropia 1.25D, cylinder up to -1.00DC 3. Best corrected visual acuity of at least 20/25 in each eye 4. Parents/guardians and participant have read and understood the Participant Information Sheet 5. Parents/guardians and participant have read, signed and dated the Informed Consent 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
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 |
|---|---|
| Visual satisfaction measured using the mean of three questions each recorded on a 0 -100 visual analogue scale at each visit (baseline, V1 dispense, V2 10 +/- 3 days later, V3 10 +/- 3 days later, V4 10 +/- 3 days later) | — |
Secondary
| Measure | Time frame |
|---|---|
| Visual acuity measured using high and low LogMar visual acuity charts at a distance of 4 metres during each visit (baseline, V1 dispense, V2 10 +/- 3 days later, V3 10 +/- 3 days later, V4 10 +/- 3 days later) | — |
Countries
United Kingdom
Contacts
Public ContactDeborah Moore
Outcome results
None listed