Clinical Evaluation of 2-Week Reusable ACUVUE 2 Vivid Style



Status:Completed
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:18 - 39
Updated:3/7/2019
Start Date:January 16, 2018
End Date:February 14, 2018

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This will be a single site, non-randomized, dispensing, brand-masked to the subject,
bilateral single treatment study. There will be 2 study visits with a 10 to 14-day contact
lens wear period between visits.


Inclusion Criteria:

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

1. The subject must 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 (i.e., willing to wear only the study lenses and not use habitual lenses
during the study).

3. Females between 18 and 39 (inclusive) years of age at the time of screening.

4. The subject's vertex corrected spherical equivalent distance refraction must be in the
range of -1.00 D to -6.00 D (inclusive) in each eye.

5. The subject's refractive cylinder must be less than or equal to 0.75 D (inclusive) in
each eye.

6. Have spherical best corrected visual acuity of 20/30 or better in each eye.

7. Be a current soft contact lens wearer in both eyes with a minimum of 6 hours/day and 5
days/week over the last month by self-report.

8. The subject must be willing to be photographed and/or video-taped.

Exclusion Criteria:

1. Currently pregnant or lactating

2. Any systemic disease (eg, Sjögren's Syndrome), allergies, infectious disease (eg,
hepatitis, tuberculosis), contagious immunosuppressive diseases (eg, HIV), autoimmune
disease (eg rheumatoid arthritis), or other diseases, by self-report, which are known
to interfere with contact lens wear and/or participation in the study (at the
investigators discretion).

3. Use of systemic medications (eg, chronic steroid use) that are known to interfere with
contact lens wear (at the investigators discretion).

4. Any previous, or planned (during the study) ocular surgery (eg, radial keratotomy,
PRK, LASIK, etc.).

5. Any previous history or signs of a contact lens-related corneal inflammatory event
(eg, past peripheral ulcer or round peripheral scar), or any other ocular abnormality
that would contraindicate contact lens wear.

6. Participation in any contact lens or lens care product clinical trial within seven (7)
days prior to study enrollment.

7. Employee or family members of clinical site (eg, Investigator, Coordinator,
Technician).
We found this trial at
1
site
Jacksonville, Florida 32256
?
mi
from
Jacksonville, FL
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