Contact Lenses With New UV-blocker Manufactured With Different Techniques



Status:Completed
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:18 - Any
Updated:5/4/2018
Start Date:February 19, 2018
End Date:April 18, 2018

Use our guide to learn which trials are right for you!

This study is a randomized, 4-visit, double-masked, 2x3 bilateral crossover, dispensing
trial. The study lenses will be worn as daily wear (DW) for a period of two weeks each with
one of the study lenses being worn twice. Each study lens is expected to be worn at least
five (5) days per week for at least six (6) hours per day worn. There will be no washout
period between study lenses.


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.

3. Healthy adult males or females age ≥18 years of age with signed informed consent.

4. Eligible presbyopes will be those that wear full distance contact lenses in both
eyes, then wear reading glasses over them.

5. The subject is a current spherical soft contact lens wearer (defined as a minimum
of 6 hours of DW per day, at least 5 days per week, for a minimum of 1 month
prior to the study) and willing to wear the study lenses on a similar basis.

6. Subjects must be able and willing to wear the study lenses at least 6 hours a
day, a minimum of 5 days per week.

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

8. The subject's refractive cylinder must be ≤ -1.00 D in each eye.

9. Have spherocylindrical best corrected visual acuity of 20/25+3 or better in each
eye.

Exclusion Criteria:

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

1. Currently pregnant or lactating.

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

3. Use of systemic medications (e.g., chronic steroid use) that are known to
interfere with contact lens wear. Habitual medications taken by successful
contact lens wearers are generally considered acceptable.

4. Habitual toric, extended wear, or multifocal contact lens wear.

5. Any current use of ocular medication.

6. Any known hypersensitivity or allergic reaction to Optifree PureMoist.

7. Any previous, or planned (during the course of the study) ocular surgery (e.g.,
radial keratotomy, PRK, LASIK, etc.).

8. Participation in any contact lens or lens care product clinical trial within 14
days prior to study enrollment.

9. Employee or immediate family member of an employee of clinical site (e.g.,
Investigator, Coordinator, Technician).

10. Any active or ongoing ocular allergies, infections or other ocular abnormalities
that are known to interfere with contact lens wear and/or participation in the
study. This may include, but not be limited to entropion, ectropion, extrusions,
chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions,
aphakia, or corneal distortion.

11. Any Grade 3 or greater slit lamp findings (e.g., edema, corneal
neovascularization, corneal staining, tarsal abnormalities, conjunctival
injection) on the FDA slit-lamp scale.

12. Binocular vision abnormality or strabismus.

13. Any previous history or signs of a contact lens-related corneal inflammatory
event (e.g., past peripheral ulcer or round peripheral scar), or any other ocular
abnormality that would contraindicate contact lens wear.
We found this trial at
5
sites
Pickens, South Carolina 29671
?
mi
from
Pickens, SC
Click here to add this to my saved trials
Foster City, California 94404
?
mi
from
Foster City, CA
Click here to add this to my saved trials
Jacksonville, Florida 32258
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
Memphis, Tennessee 38111
?
mi
from
Memphis, TN
Click here to add this to my saved trials
2319 Highland Drive
Salt Lake City, Utah 84106
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials