Senofilcon A Investigational Manufacturing Process



Status:Completed
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:18 - 70
Updated:6/21/2018
Start Date:September 2013
End Date:December 2013

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

Clinical Investigation of Senofilcon A Manufactured Using an Alternate Hydration Process

To evaluate the impact of a new contact lens hydration process

To evaluate the impact on clinical performance of senofilcon A lenses manufactured using an
alternate hydration process and compare the performance with senofilcon A lenses manufactured
using the current process.

Inclusion Criteria:

- The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and
receive a fully executed copy of the form.

- The subject must appear able and willing to adhere to the instructions set forth in
this clinical protocol.

- The subject must be at least 18 and not more than 70 years of age.

- The subject's refractive cylinder must be < 0.75D in each eye.

- The subject must have best corrected visual acuity of 20/25 or better in each eye.

- The subject must demonstrate adequate mobility and 20/30 vision OD and OS with the
study contact lenses.

- The subject must be a habitual and adapted wearer of ACUVUE® OASYS® Brand contact lens
in both eyes.

- The subject must have normal eyes (i.e., no ocular medications or infections of any
type).

- The subject's required spherical contact lens prescription must be in the range of
-0.50 to -9.00D in each eye.

Exclusion Criteria:

- Currently pregnant or lactating (subjects who become pregnant during the study will be
discontinued).

- Any ocular or systemic allergies or diseases that may interfere with contact lens
wear.

- Any systemic disease, autoimmune disease, or use of medication, that may interfere
with contact lens wear.

- Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of
recurrent corneal erosions, aphakia, or moderate or above corneal distortion by
keratometry.

- Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, PRK,
LASIK, etc.).

- Any grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization,
corneal staining, tarsal abnormalities, conjunctival injection) on the FDA
classification scale, 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 may contraindicate contact lens wear.

- Any known hypersensitivity or allergic reaction to OPTI-FREE® PureMoist® Contact Lens
Solution.

- Any ocular infection.

- Any corneal distortion resulting from previous hard or rigid gas permeable contact
lens wear.

- Monovision or multi-focal contact lens correction.

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

- History of binocular vision abnormality or strabismus.

- Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious
immunosuppressive disease (e.g., HIV, by self report).

- Suspicion of or recent history of alcohol or substance abuse.

- History of serious mental illness.

- History of seizures.

- Employee of investigational clinic (e.g., Investigator, Coordinator, Technician)
We found this trial at
4
sites
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
?
mi
from
Bloomington, IL
Click here to add this to my saved trials
?
mi
from
Pittsburg, KS
Click here to add this to my saved trials
?
mi
from
Warwick, RI
Click here to add this to my saved trials