Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2025-12-24 @ 6:40 PM
NCT ID:
NCT03312257
Eligibility Criteria:
Inclusion Criteria:
* 7 to 11 years, inclusive, at baseline examination
* -0.75 to -5.00 D, inclusive, spherical component, cycloplegic autorefraction
* ≤1.00 DC, cycloplegic autorefraction
* ≤ 2.00 D difference between the sphere components of the two eyes (anisometropia), cycloplegic autorefraction
* 0.1 logMAR or better best-corrected visual acuity in each eye
* 0.1 logMAR or better visual acuity OU distance and near with a +2.50 D add contact lens
* +2.50 D add lens provides adequate fit with respect to movement and centration
* Finish at least 71% of 0.01% atropine during the run-in period
Exclusion Criteria:
* Eye disease or binocular vision problems (e.g., strabismus, amblyopia, oculomotor nerve palsies, corneal disease, etc.)
* Previous intraocular or corneal surgery
* Systemic disease that may affect vision, vision development, or contact lens wear (eg, diabetes, Down syndrome, etc.)
* Previous gas permeable, soft bifocal, or orthokeratology contact lens wear or bifocal/PAL spectacle wear (longer than 1 month of wear)
* Previous or current participation in myopia control studies
* Chronic use of medications that may affect immunity, such as oral or ophthalmic corticosteroids for ocular or systemic diseases
* Issues that may interfere with the ability to participate over the next 3 years
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
7 Years
Maximum Age:
11 Years
Study:
NCT03312257
Study Brief:
Protocol Section:
NCT03312257