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 @ 5:49 PM
Ignite Modification Date:
2025-12-24 @ 5:49 PM
NCT ID:
NCT01518868
Eligibility Criteria:
Inclusion Criteria:
* Have physiologically normal anterior segments
* Be adapted wearers of soft contact lenses and wear a lens in each eye.
* Be presbyopic and require near add correction in each eye.
* Be an adapted monovision or multifocal contact lens wearer or be an adapted spherical lens wearer who also uses spectacles for near vision correction.
* Have no active ocular disease or allergic conjunctivitis.
* Must not be using any topical ocular medications.
* Must habitually use a lens care product for lens cleaning, disinfecting, and storage.
Exclusion Criteria:
* Any Grade 2 or greater finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
* Any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
* Anisometropia (spherical equivalent) of greater than 2.00 D.
* Any systemic disease affecting ocular health.
* Using any systemic or topical medications that will affect ocular physiology or lens performance.
* Allergic to any component in the study products.
* Ocular astigmatism of greater than 1.00 D in either eye.
* Have had any corneal surgery (ie, refractive surgery).
* Uses AMO Ultra Care as their habitual lens care regimen.
* Is a toric contact lens wearer.
* Have worn gas permeable (GP) contact lenses within last 30 days or PMMA lenses within last 3 months.
* An active ocular disease (for example but not limited to papillary conjunctivitis, any conjunctivitis: viral, bacterial, allergic), any corneal infiltrative response or are using any ocular medications.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01518868
Study Brief:
Protocol Section:
NCT01518868