Evaluation of an Investigational Multifocal Lens



Status:Completed
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:40 - 70
Updated:6/21/2018
Start Date:August 2014
End Date:November 2014

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The purpose of this study is to test the performance of an investigational multifocal test
soft contact lens.


Inclusion Criteria:

1. The subjects were required to have read, understand, and signed 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. Between 40 and 70 years of age.

4. Subjects must own a wearable pair of spectacles, if required for their distance
vision.

5. 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 of more duration)

6. Already be wearing a presbyopic contact lens correction (e.g., reading spectacles over
contact lenses, multifocal or monovision contact lenses, etc.) or if not respond
positively to at least one symptom on the "Presbyopic Symptoms Questionnaire"*

7. The subject's vertex corrected spherical equivalent distance refraction was required
to be in the range +3.50 to -5.75 in each eye.

8. Refractive cylinder ≤ -0.75 D in each eye.

9. ADD power in the range +0.75 D to +2.50 D in each eye.

10. Best corrected visual acuity of 20/20-3 or better in each eye.

Exclusion Criteria:

1. Currently pregnant or lactating (subjects who became pregnant during the study were
discontinued).

2. Any ocular or systemic allergies that may have contraindicated contact lens wear.

3. Any ocular or systemic disease, autoimmune disease, or use of medication, that may
have contraindicated contact lens wear.

4. Any ocular abnormality that may have interfered with contact lens wear.

5. Use of any ocular medication, with the exception of rewetting drops.

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

7. History of herpetic keratitis.

8. History of binocular vision abnormality or strabismus.

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

10. History of diabetes.

11. Participation in any contact lens or lens care product clinical trial within 30 days
prior to study enrollment.

12. 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.

13. Any ocular infection or inflammation.

14. Any corneal distortion or irregular cornea.
We found this trial at
19
sites
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Tampa, FL
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Denver, NC
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East Lansing, MI
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Jacksonville, FL
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Memphis, TN
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Mission Viejo, California 92691
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Mission Viejo, CA
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Montgomery, AL
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Orange Park, FL
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Pittsburg, KS
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Powell, OH
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Roswell, GA
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from
Saint Augustine, FL
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Salem, VA
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from
Springfield, OH
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Tallahassee, FL
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Tyler, TX
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Vestal, NY
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Warwick, RI
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Winter Park, FL
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