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
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Winter Park, FL
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from
Amarillo, TX
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from
Athens, OH
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from
Closter, NJ
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mi
from
Denver, NC
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RPS
Jacksonville, Florida
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mi
from
Jacksonville, FL
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mi
from
Jacksonville, FL
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mi
from
Kingston, PA
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mi
from
Lutherville, MD
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mi
from
Memphis, TN
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Mission Viejo, California 92691
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mi
from
Mission Viejo, CA
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mi
from
New York, NY
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mi
from
Roswell, GA
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mi
from
Saint Augustine, FL
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mi
from
Salem, VA
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mi
from
Salt Lake City, UT
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mi
from
Tallahassee, FL
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mi
from
Tyler, TX
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mi
from
Warwick, RI
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