Clinical Study of Approved Contact Lenses



Status:Completed
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:18 - Any
Updated:1/21/2018
Start Date:October 23, 2017
End Date:December 8, 2017

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Evaluation of Johnson & Johnson Acuvue Vita (senofilcon C) soft contact lenses to the Bausch
+ Lomb Ultra (samfilcon A) soft contact lenses

to compare the performance of currently marketed Johnson & Johnson Acuvue Vita (senofilcon C)
soft contact lenses to the currently marketed Bausch + Lomb Ultra (samfilcon A) soft contact
lenses among adapted wearers of Acuvue Oasys soft contact lenses.

Inclusion Criteria:

1. Subjects must be between the ages of 18 and 40 years old, inclusive, on the date the
Informed Consent Form (ICF) is signed and have the capacity to provide voluntary
informed consent.

2. Subjects must be able to read, understand and provide written informed consent on the
Institutional Review Board (IRB)/Ethics Committee (EC) approved ICF and provide
authorization as appropriate for local privacy regulations.

3. Subjects must be willing and able to comply with all treatment and follow-up/study
procedures.

4. Subjects must be correctable through spherocylindrical refraction to 32 letters (0.3
logMAR) or better (distance, high contrast) in each eye.

5. Subjects must have clear central corneas and be free of any anterior segment
disorders.

6. Subjects must be myopic and require contact lens sphere power correction from -0.50
diopter (D) to -6.00 D (considering vertex distance adjustments in both eyes).

7. Subjects must be habitual wearers of Johnson & Johnson Acuvue Oasys single vision
spherical soft contact lenses in each eye.

8. Subjects must use a contact lens care regimen on a routine basis.

9. Subjects must agree to wear their study lenses on a daily wear basis for the duration

Exclusion Criteria:

1. Subjects participating in any drug or device clinical investigation within two weeks
prior to entry into this study and/or during the period of study participation

2. Subjects who are women of childbearing potential (those who are not surgically
sterilized or postmenopausal) are excluded from participation in the investigation if
they meet any one of the following conditions:

- she is currently pregnant

- she plans to become pregnant during the study

- she is breastfeeding

3. Subjects with any systemic disease currently affecting ocular health or which in the
Investigator's opinion may have an effect on ocular health during the course of the
study.

4. Subjects using any systemic or topical medications that will, in the Investigator's
opinion, affect ocular physiology or lens performance.
We found this trial at
10
sites
Pittsburg, Kansas 66762
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Denver, Colorado 80123
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Denver, CO
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New Berlin, Wisconsin 53151
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New Berlin, WI
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Orlando, Florida 32812
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Orlando, FL
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10 Powell Road
Powell, Ohio 43065
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Powell, OH
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San Diego, California 92123
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San Diego, CA
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San Francisco, California 94112
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San Francisco, CA
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Sarasota, Florida 34232
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Sarasota, FL
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Vestal, New York 13850
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Vestal, NY
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Warrensburg, Missouri 64093
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Warrensburg, MO
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