Clinical Evaluation of Etafilcon A Contact Lenses Using a Novel Molding Process 2



Status:Completed
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:18 - 70
Updated:1/11/2019
Start Date:September 24, 2018
End Date:December 11, 2018

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This study is a multi-site, group sequential, adaptive, randomized, double-masked, 2×2
crossover design, 1-week dispensing study. Subjects will wear bilaterally both Test and
Control lenses in a random order for 1-week each as a daily disposable modality with a
wash-out period of 1 week between the wearing periods.


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. Must be at least 18 and not more than 70 years of age (including 70) at the time
of screening.

4. The subject must be a habitual and adapted wearer of hydrogel daily disposable
brand contact lens in both eyes (at least 1 month of daily wear).

5. The subject must have normal eyes (i.e., no ocular medications or infections of
any type).

6. The subject's required spherical contact lens prescription must be in the range
of -1.00 to -4.50 D in each eye.

7. The subject's refractive cylinder must be < 0.75 D in each eye.

8. The subject must have best corrected 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 in the study:

1. Currently pregnant or lactating (subjects who become pregnant during the study
will be discontinued).

2. Any systemic disease, autoimmune disease, or use of medication that may interfere
with contact lens wear.

3. Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy,
PRK, LASIK, etc.).

4. Any ocular infection.

5. Any corneal distortion resulting from previous hard or rigid gas permeable
contact lens wear.

6. Monovision or multi-focal contact lens correction.

7. Participation in any contact lens or lens care product clinical trial within 14
days prior to study enrollment.

8. History of binocular vision abnormality or strabismus.

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

10. Suspicion of or recent history of alcohol or substance abuse.

11. History of serious mental illness.

12. History of seizures.

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

14. 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.

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

16. Any previous history or signs of a contact lens-related corneal inflammatory
event (e.g., past peripheral ulcer or round peripheral scar), or any other ocular
abnormality that may contraindicate contact lens wear.
We found this trial at
12
sites
Rocklin, California 95677
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Rocklin, CA
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Brentwood, Tennessee 37027
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Brentwood, TN
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Fleming Island, Florida 32258
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Fleming Island, FL
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1955 Newark Granville Road
Granville, Ohio 43023
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Granville, OH
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Jacksonville, Florida 32258
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Jacksonville, FL
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105 East Lake Brantley Drive
Longwood, Florida 32779
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from
Longwood, FL
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600 South Orlando Avenue
Maitland, Florida 32751
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Maitland, FL
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Memphis, Tennessee
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Memphis, TN
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9711 Sawmill Parkway
Powell, Ohio 43065
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Powell, OH
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Saint Augustine, Florida 32092
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Saint Augustine, FL
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Salem, Virginia 24153
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Salem, VA
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Vestal, New York 13850
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Vestal, NY
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