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:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2025-12-25 @ 3:47 AM
NCT ID:
NCT01526902
Eligibility Criteria:
Inclusion Criteria:
* Be between 40 and 65 years of age (inclusive)
* Require a reading addition of +1.25 to +2.50D (inclusive)
* Spherical distance CL or spectacle prescription between +3.00D and -5.00D(inclusive)
* Spectacle cylinder less than or equal to 0.75D in both eyes.
* Currently has a reading add correction in their spectacle or CL habitual correction (e.g. if myope, removes distance correction to read)
* Normal binocularity (no amblyopia, no strabismus, no habitually uncorrected anisometropia ≥ 2.00D)
* Have a minimum 2 weeks soft contact lens experience
* Be able to wear the study lens (e.g. good fit is attained and acceptable subjective comfort and vision for the duration of the study)
* Able to read, comprehend and sign an informed consent
* Willing to comply with the wear and study visit schedule
* Monocular best-corrected distance visual acuity ≥ 20/25 in each eye
* No gas permeable contact lens wear for 1 month prior to the study
Exclusion Criteria:
To be eligible for the study, each candidate must not present with any of the following
* Any active corneal infection, injury, inflammation, or ocular abnormality
* Systemic or ocular allergies, which might interfere with contact lens wear
* Systemic disease, which might interfere with contact lens wear
* Ocular disease, which might interfere with contact lens wear
* Pregnant or lactating
* Strabismus/amblyopia
* Habitually uncorrected anisometropia greater than or equal to 2.00 D
* Subjects who have undergone corneal refractive surgery
* Subjects with keratoconus or other severe corneal irregularity contraindicating lens wear
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
65 Years
Study:
NCT01526902
Study Brief:
Protocol Section:
NCT01526902