Clinical Evaluation of Lapsed Contact Lens Wearers Who Are Re-fit Into Senofilcon A Contact Lenses



Status:Completed
Healthy:No
Age Range:18 - 40
Updated:6/21/2018
Start Date:November 2013
End Date:April 2014

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

A Multi-Center Clinical Evaluation of Lapsed Contact Lens Wearers Who Are Re-Fit Into Spherical or Toric Senofilcon A Contact Lenses

This study is an open-label, multi-site study. The total number of subjects was 200. The
duration of this study was approximately four weeks. The primary objective was to assess what
percentage of lapsed contact wearers, who have discontinued use of their contact lenses for
greater than six months can be successfully re-fit with senofilcon A, reusable 2-weekly
replacement daily wear lenses (spherical and toric designs).


Inclusion Criteria:

1. The subject must read, understand , and sign the Statement of Informed Consent and
receive a fully executed copy of the form.

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

3. The subject must be interested in wearing contact lenses.

4. The subject must be at least 18 years old or less than 40 years of age at the time of
consent.

5. The subject's vertexed spherical cylindrical refraction must result in a contact lens
prescription for each eye that is available in the investigator's choice of study
contact lens material(s).

6. The subject must have best corrected visual acuity of 20/30 or better in each eye.

7. The subject must require visual correction in both eyes.

8. The subject must be a lapsed wearer (defined as, any non-contact lens wearer requiring
optical correction who has been previously fitted in and has previously purchased
contact lenses but has since discontinued contact lens wear for any reason more than 6
months prior to the time of consent).

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

Exclusion Criteria:

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

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

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

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

5. Any previous, or planned, ocular or intraocular surgery (e.g., radial keratotomy,
photorefractive keratectomy (PRK), LASIK, etc.)

6. 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 tha may contraindicate contact lens wear.

7. Any ocular infection.

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

9. Participation in any contact lens or lens care trial within one year prior to study
enrollment.

10. History of binocular vision abnormality or strabismus.

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

12. Employee of the investigational clinic (i.e., Investigator, Coordinator, or
Technician).
We found this trial at
10
sites
?
mi
from
Bloomington, IL
Click here to add this to my saved trials
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
?
mi
from
Memphis, TN
Click here to add this to my saved trials
?
mi
from
Raleigh, NC
Click here to add this to my saved trials
?
mi
from
Raytown, MO
Click here to add this to my saved trials
?
mi
from
Roswell, GA
Click here to add this to my saved trials
?
mi
from
Saint Augustine, FL
Click here to add this to my saved trials
?
mi
from
Sarasota, FL
Click here to add this to my saved trials
?
mi
from
Vestal, NY
Click here to add this to my saved trials
?
mi
from
Warwick, RI
Click here to add this to my saved trials