Myopia Eye Diseases
Conditions
Interventions
The study will be a randomized, double-masked prospective daily disposable study involving four study visits over approximately five weeks of wear, consisting of a 1-week crossover phase followed by a
Sponsors
CooperVision International Limited
Eligibility
Sex/Gender
All
Age
8 Years to 18 Years
Inclusion criteria
Inclusion criteria: 1. Age 8 to 18 years; at least half the population will be children or adolescents aged 8 to 15 years 2. Have experience with soft contact lens wear and able to insert and remove soft contact lenses 3. Parent/guardian and participant have read and understood the Participant Information Sheet 4. Parent/guardian and participant have read, signed and dated the Informed Consent and Assent (when applicable) 5. Best corrected visual acuity of at least 20/25 in each eye 6. Have normal eyes except for the need for visual correction 7. Spectacle refraction: 7.1. Age 8 to 12: -0.75D to -4.00D spherical equivalent, with cylinder = -0.75D and maximum anisometropia of <1.00D 7.2. Age 13-18: -0.75D to -7.00D spherical equivalent, with cylinder = -0.75D and maximum anisometropia of <1.00D 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. Acute and subacute inflammation or infection of the anterior chamber of the eye 2. Any eye disease, injury, or abnormality that affects the cornea, conjunctiva, or eyelids 3. Severe insufficiency of lacrimal secretion (dry eyes) 4. Corneal hypoesthesia (reduced corneal sensitivity), if not aphakic 5. Any systemic disease that may affect the eye or be exaggerated by wearing contact lenses 6. Allergic reactions of ocular surfaces or adnexa that may be induced or exaggerated by wearing contact lenses or use of contact lens solutions 7. Any active corneal infection (bacterial, fungal, or viral) 8. The patient is unable to follow lens handling and wear regimen or is unable to obtain assistance to do so 9. Newly prescribed use of systemic or ocular medications for which contact lens wear could be contraindicated as determined by the investigator 10. Monocular participants (only one eye with functional vision) or participants fit with only one lens 11. 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 11980:2012, 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 12. History of herpetic keratitis, ocular surgery or irregular cornea 13. 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 |
|---|---|
| The hierarchical primary outcome measures that follow will be assessed at one-week follow-up visits after at least three hours of wear: 1. Total absolute decentration from pupil centre in mm measured using slit lamp biomicroscope with a digital recording attachment during the visit 2. Contact lens centration clinical rating measured using a forced choice clinical scale during the visit 3. Contact lens movement at blink clinical rating measured using a forced choice clinical scale during the visit | — |
Secondary
| Measure | Time frame |
|---|---|
| The are no secondary outcome measures | — |
Countries
England, United Kingdom
Contacts
Public ContactDeborah Moore
Outcome results
None listed