Evaluation of Senofilcon A With New UV-blocker on a Neophyte Population



Status:Recruiting
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:18 - 39
Updated:3/28/2019
Start Date:October 30, 2018
End Date:March 31, 2019
Contact:John R Buch, OD, MS, FAAO
Email:jbuch@its.jnj.com
Phone:1-800-843-2020

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This is a 5-visit, single-arm, open-label, dispensing study. Each subject will be bilaterally
fit with the test article for approximately 4 weeks of reusable daily wear with lens
replacement occurring 2-weeks after initial dispensing. After 4 weeks of study lens wear,
subjects will return to their habitual spectacles for one week.


Inclusion Criteria:

- Potential subjects must satisfy all of the following criteria to be enrolled in the
study:

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

2. Appear able and willing to adhere to the instructions set forth in this clinical
protocol.

3. Between 18 and 39 (inclusive) years of age at the time of screening.

4. They are a contact lens 'neophyte'. In this work 'neophyte' is taken to mean any
subject who has never been dispensed contact lenses. A subject who had taken part
in a non-dispensing clinical study or had been fitted with contact lenses in
practice but never went on to actually wear the lenses, is also classified as a
'neophyte'.

5. Habitual spectacles must have resulted from an eye exam within the past six
months.

6. The subject must have worn the updated spectacles for at least two weeks.

7. Be a current wearer of prescription spectacles that provide corrected monocular
visual acuity of 20/25 or better in each eye.

8. The subject's vertex corrected spherical equivalent distance refraction must be
in the range of -1.00 to -6.00 D (inclusive) in each eye.

9. The subject's refractive cylinder must be -1.00 D or less in each eye.

10. Have spherocylindrical best corrected distance Snellen visual acuity of 20/25 or
better in each eye.

Exclusion Criteria:

- Potential subjects who meet any of the following criteria will be excluded from
participating

1. Currently pregnant or lactating.

2. Any active or ongoing systemic disease (e.g., Sjögren's Syndrome), allergies,
infectious disease (e.g., hepatitis, tuberculosis), contagious immunosuppressive
diseases (e.g., HIV), autoimmune disease (e.g. rheumatoid arthritis), or other
diseases, by self-report, which are known to interfere with contact lens wear
and/or participation in the study.

3. Use of systemic medications that have a high likelihood to interfere with contact
lens wear (estrogens, antihistamines, anticholinergics, beta-blockers, and
psychotropics).

4. Any current use of ocular medication.

5. Any known hypersensitivity or allergic reaction to any ingredient in Opti-Free
PureMoist.

6. Any previous or planned (during the course of the study) ocular surgery (e.g.,
radial keratotomy, PRK, LASIK, etc.).

7. Employee or immediate family member of an employee of clinical site (e.g.,
Investigator, Coordinator, Technician).

8. Any ocular allergies, infections or other ocular abnormalities that are known to
interfere with contact lens wear and/or participation in the study. This may
include, but not be limited to entropion, ectropion, extrusions, chalazia,
recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or
corneal distortion.

9. Any Grade 3 or 4 slit lamp findings (e.g., edema, corneal neovascularization,
corneal staining, tarsal abnormalities, conjunctival injection) on the FDA slit
lamp classification scale.

10. Binocular vision abnormality or strabismus.
We found this trial at
10
sites
Jacksonville, Florida 32205
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5341 Wyoming Boulevard Northeast
Albuquerque, New Mexico 87109
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Greensboro, Georgia 30642
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Greensboro, GA
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Jacksonville Beach, Florida 32250
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Jacksonville Beach, FL
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105 East Lake Brantley Drive
Longwood, Florida 32779
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Longwood, FL
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Macclenny, Florida 32063
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Macclenny, FL
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9711 Sawmill Parkway
Powell, Ohio 43065
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Powell, OH
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Raytown, Missouri 64133
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Raytown, MO
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5777 New Copeland Road
Tyler, Texas 75703
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Tyler, TX
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Vestal, New York 13850
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Vestal, NY
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