Condition

• Visual Acuity

Eligibility

Eligible Ages

Between 18 Years and 69 Years

Eligible Sex

All

Accepts Healthy Volunteers

Yes

Criteria

Potential subjects must satisfy all of the following criteria to be enrolled in the
study:

1. Read, understand, and sign the Statement of Informed Consent and receive a fully
executed copy of the form.

2. Appear able and willing to adhere to the instructions set forth in this clinical
protocol.

3. Be between 18 and 69 years of age (inclusive) at the time of screening.

4. Habitually wear soft contact lenses (either spherical or multifocal) in both eyes in
a daily reusable or daily disposable wear modality (i.e., not extended wear
modality). Habitual wearer is defined as a minimum of 6 hours per day, for a minimum
of 2 days per week during the past 30 days.

5. Possess a wearable pair of spectacles that provide correction for distance vision.

6. Have the spherical component of their vertex-corrected distance refraction within
the range +3.00 to -5.00 DS (inclusive) in both eyes.

7. Have the magnitude of the cylindrical component of their vertex-corrected distance
refraction below 1.00 DC in both eyes.

8. Have best corrected monocular distance VA of 20/25 or better in each eye.

9. Have Near Addition with Add refinement following BCC<0.75D (Non-presbyopic group
only).

10. Have Near Addition with Add refinement following BCC≥0.75D (Presbyopic group only).

Potential subjects who meet any of the following criteria will be excluded from
participating in the study:

1. Be currently pregnant or lactating.

2. Be diabetic.

3. Be currently using any ocular medications or have an ocular infection of any type.

4. Have any ocular or systemic allergies, disease, infection, or use of medication that
might contraindicate or interfere with contact lens wear or otherwise compromise
study endpoints, including infectious diseases (e.g., hepatitis, tuberculosis),
contagious immunosuppressive disease (e.g., Human Immunodeficiency Virus [HIV]), or
history of serious mental illness or seizures. See section 9.1 for additional
details regarding systemic medications.

5. Have habitually worn rigid gas permeable (RGP) lenses, orthokeratology lenses, or
hybrid lenses (e.g., SynergEyes, SoftPerm) within the past 6 months.

6. Be currently wearing lenses in an extended wear modality.

7. Have a history of strabismus or amblyopia.

8. Be an employee (e.g., Investigator, Coordinator, Technician) or immediate family
member of an employee (including partner, child, parent, grandparent, grandchild or
sibling of the employee or their spouse) of the clinical site.

9. Have participated in a contact lens or lens care product clinical trial within 7
days prior to study enrollment.

10. Have clinically significant (Grade 3 or 4 on the FDA classification scale) slit lamp
findings (e.g. corneal edema, neovascularization or staining, tarsal abnormalities
or bulbar injection) or other corneal or ocular disease or abnormalities that may
contraindicate contact lens wear or otherwise compromise study endpoints (including
entropion, ectropion, chalazia, recurrent styes, glaucoma, history of recurrent
corneal erosions, aphakia, moderate or above corneal distortion, herpetic
keratitis).

11. Have fluctuations in vision due to clinically significant dry eye or other ocular
conditions.

12. Have had or have planned (within the study period) ocular or intraocular surgery
(e.g., radial keratotomy, PRK, LASIK, etc.)

Recruiting Locations

Study Contact

Detailed Description

Optical scatter may affect young adults or non-presbyopes and older adults or presbyopes differently. Intrinsic ocular scatter increases with age and ocular scatter sensitivity as well as profile is different in younger adults and older adults.