Evaluation of the Performance of Investigational Contact Lenses in a Presbyopic Population



Status:Completed
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:40 - 70
Updated:6/21/2018
Start Date:November 2012
End Date:February 2013

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The objective of this study is to evaluate the performance of a novel multifocal lens system.


Inclusion Criteria:

1. Subjects must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive
a fully executed copy of the form.

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

3. Subjects must be between 40 and 70 years of age.

4. Subjects' spherical equivalent distance refraction must be in the range of -3.75 to
+3.75 in each eye.

5. Subjects' refractive cylinder must be less than or equal to 0.75D in each eye.

6. Subjects' ADD power must be in the range of +0.75 to +2.50D in each eye.

7. Subjects' must have the best corrected visual acuity of 20/20-3 or better in each eye.

8. Subjects' should own a wearable pair of spectacles.

9. Subjects' must be an adapted soft contact lens wearer in both eyes (i.e. worn lenses a
minimum of 2 days per week for at least 8 hours per wear day, for 1 month or more
duration).

10. Subjects' must respond positively to at least on symptom on the "Presbyopis Symptoms
Questionnaire" or already be wearing a presbyopic contact lens correction (e.g.
reading spectacles over contact lenses, multifocal or monovision contact lenses,
etc.).

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. Any previous intraocular surgery (e.g. radial keratotomy, PRK, LASIK, etc.)

5. Any grade 3 or greater slit lamp findings (e.g. edema, corneal neovascularization,
corneal staining, tarsal abnormalities, conjunctival injection) which may
contraindicate contact lens wear.

6. Any ocular infection.

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

8. History of binocular vision abnormality or strabismus.

9. Any infectious disease (e.g. hepatitis, tuberculosis) or contagious immunosuppressive
disease (e.g. HIV).

10. History of diabetes.

11. Participation in any contact lens or lens care product clinical trial within 7 days
prior to study enrollment.
We found this trial at
19
sites
615
mi
from 43215
Warwick, RI
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1078
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from 43215
Amarillo, TX
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65
mi
from 43215
Athens, OH
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481
mi
from 43215
Closter, NJ
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325
mi
from 43215
Denver, NC
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RPS
Jacksonville, Florida
?
mi
from 43215
Jacksonville, FL
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668
mi
from 43215
Jacksonville, FL
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384
mi
from 43215
Kingston, PA
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?
mi
from 43215
Lutherville, MD
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508
mi
from 43215
Memphis, TN
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Mission Viejo, California 92691
1953
mi
from 43215
Mission Viejo, CA
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481
mi
from 43215
New York, NY
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416
mi
from 43215
Roswell, GA
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702
mi
from 43215
Saint Augustine, FL
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243
mi
from 43215
Salem, VA
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1513
mi
from 43215
Salt Lake City, UT
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661
mi
from 43215
Tallahassee, FL
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862
mi
from 43215
Tyler, TX
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791
mi
from 43215
Winter Park, FL
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