Myopia Eye Diseases
Conditions
Interventions
The study will be a randomized, bilateral, 12-week crossover study comparing myopic control soft daily disposable contact lenses and spectacles in myopic children.
Block randomization will be compute
Sponsors
CooperVision International Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: To be enrolled, each participant shall meet the following criteria: 1. Age 8 to 12 years 2. They have no previous experience with contact lenses 3. The parent or guardian understands the study and rights of the participant and is willing to sign a statement of informed consent 4. The participant understands the study at a level appropriate for their age and is willing to sign a statement of assent 5. They are willing and able to follow the protocol
Exclusion criteria
Exclusion criteria: The following are specific criteria that exclude a candidate from enrolment in this study: 1. Ocular disorder that would normally contraindicate contact lens wear 2. Corneal refractive surgery or have an irregular cornea 3. Use of systemic or ocular medication that would contraindicate contact lens wear 4. Candidate is aphakic 5. Participation in a contact lens or lens care product trial in the previous 30 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intervention preference between spectacles versus contact lenses will be measured by asking subjects to provide their overall preferred intervention and the reasons for their choice using a 5-point Likert scale at the 12-week timepoint. In addition, where a participant selects the neutral option, a follow-up question will be asked to “force” them to decide. Reasons for their choice will also be collected. | — |
Secondary
| Measure | Time frame |
|---|---|
| There are no secondary outcome measures | — |
Countries
England, United Kingdom
Contacts
Public ContactJose;Philip Vega;Morgan
;
Outcome results
None listed