Clinical Evaluation of Approved Contact Lenses



Status:Completed
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:18 - 70
Updated:5/6/2016
Start Date:February 2016
End Date:April 2016

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This is a 4-week, randomized, double-masked study where subjects will wear bilaterally test
and control lenses in random succession. The objective is to evaluate materials from
different suppliers.


Inclusion Criteria:

1. The subject must read, understand, and sign 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. The subject must be at least 18 and not more than 70 years of age (including 70).

4. The subject's refractive cylinder must be < 0.75 Diopters (D) in each eye.

5. The subject must have best corrected visual acuity of 20/25 or better in each eye.

6. The subject must be a habitual and adapted wearer of ACUVUE® OASYS® brand contact
lens in both eyes (at least 1 month of daily wear).

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

8. The subject's required spherical contact lens prescription must be in the range of
-1.00 D to -6.00 D in each eye.

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 that may interfere
with contact lens wear.

4. Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of
recurrent corneal erosions, aphakia.

5. Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy,
photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (LASIK),
etc.)

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

7. Any known hypersensitivity or allergic reaction to OPTI-FREE® PureMoist® Contact Lens
Solution.

8. Any ocular infection.

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

10. Monovision or multi-focal contact lens correction.

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

12. History of binocular vision abnormality or strabismus.

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

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

15. History of serious mental illness.

16. History of seizures.

17. Employee of investigational clinic (e.g., Investigator, Coordinator, Technician)
We found this trial at
7
sites
Sarasota, Florida 34242
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
Phone: 205-934-5109
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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Jacksonville, Florida 32256
Principal Investigator: Manish Patel, OD
Phone: 904-538-0868
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Jacksonville, FL
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Neodesha, Kansas 66757
Principal Investigator: Shane Kannarr, OD
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Neodesha, KS
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Raytown, Missouri 64133
Phone: 816-353-1872
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Raytown, MO
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Roanoke, Virginia 24153
Principal Investigator: Timothy R. Poling, OD
Phone: 540-797-2780
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Roanoke, VA
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Westerville, Ohio 43081
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Westerville, OH
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