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
2088
mi
from 91732
Denver, NC
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922
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from 91732
Amarillo, TX
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2008
mi
from 91732
Athens, OH
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2434
mi
from 91732
Closter, NJ
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RPS
Jacksonville, Florida
?
mi
from 91732
Jacksonville, FL
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2127
mi
from 91732
Jacksonville, FL
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2332
mi
from 91732
Kingston, PA
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?
mi
from 91732
Lutherville, MD
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1586
mi
from 91732
Memphis, TN
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Mission Viejo, California 92691
37
mi
from 91732
Mission Viejo, CA
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2435
mi
from 91732
New York, NY
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1919
mi
from 91732
Roswell, GA
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2158
mi
from 91732
Saint Augustine, FL
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2126
mi
from 91732
Salem, VA
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570
mi
from 91732
Salt Lake City, UT
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1977
mi
from 91732
Tallahassee, FL
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1315
mi
from 91732
Tyler, TX
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2560
mi
from 91732
Warwick, RI
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2184
mi
from 91732
Winter Park, FL
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