Initial Evaluation of Investigational Lenses Manufactured on a New Production Line



Status:Completed
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:18 - 49
Updated:11/16/2018
Start Date:August 29, 2018
End Date:November 1, 2018

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This study is a randomized, 4-visit, subject-masked, 2x3 bilateral crossover, dispensing
trial. Each study lens will be worn bilaterally in a daily wear (DW) modality for at least 6
hours per day and 5 days per week for approximately two weeks each. The subject will wear
either the Test or Control lens twice and the other study lens once.


Inclusion Criteria:

1. The subject must read and sign the Informed Consent form.

2. The subject must appear able and willing to adhere to the instructions set forth in
this clinical protocol.

3. Healthy adult males or females age ≥18 and ≤49 years of age with signed informed
consent. Eligible presbyopes will be those that wear full distance contact lenses in
both eyes, then wear reading glasses over them.

4. The subject's optimal vertexed spherical equivalent distance correction must be
between -1.00 and -6.00 D.

5. The subject's refractive cylinder must be ≤ 1.00 D in each eye.

6. The subject must have visual acuity best correctable to 20/25+3 or better for each
eye.

7. Subjects must own a wearable pair of spectacles.

8. The subject is a current spherical soft contact lens wearer (defined as a minimum of 6
hours of DW per day, at least 5 days per week, for a minimum of 1 month prior to the
study) and willing to wear the study lenses on a similar basis.

9. Subjects must be able and willing to wear the study lenses at least 6 hours a day, a
minimum of 5 days per week.

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

Exclusion Criteria:

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, which may interfere
with contact lens wear. This may include, but not be limited to, diabetes,
hyperthyroidism, recurrent herpes simplex/zoster, Sjögren's syndrome, xerophthalmia,
acne rosacea, Stevens-Johnson syndrome, and immunosuppressive diseases or any
infectious diseases (e.g. hepatitis, tuberculosis).

3. Use of any of the following medications within 1 week prior to enrollment: oral
retinoid isotretinoin (e.g. Accutane), oral tetracyclines, topical scopolamine, oral
(e.g., Chlor-Trimeton, and Benadryl) and ophthalmic antihistamines, oral
phenothiazines (e.g., Haldol, Mellaril, Thorazine, Elavil, Pamelor, Compazine), oral
and ophthalmic Beta-adrenergic blockers (e.g., Propranolol, Timolol, and Practolol),
systemic steroids, and any prescribed or over the counter (OTC) ocular medication.

4. Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of
recurrent corneal erosions, aphakia, or moderate or above corneal distortion.

5. Any previous, or planned, ocular or intraocular surgery (e.g., radial keratotomy,
photorefractive keratectomy (PRK), 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 Optifree® PureMoist® multi-purpose
care solution or Eye-Cept® rewetting drop solution.

8. Any ocular infection, allergy or clinically significant ocular disease (e.g. corneal
edema, uveitis, severe keratoconjunctivitis sicca, ocular hypertension), or ocular
conditions (e.g. strabismus), which might interfere with the study.

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

10. Toric, extended wear, monovision or multi-focal contact lens correction.

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

12. Participation in clinical trials involving the Test lens within 3 months prior to
study enrollment.

13. History of binocular vision abnormality or strabismus.

14. Employee, relative or friends of employees of any ophthalmic company, or
investigational clinic (e.g., Investigator, Coordinator, Technician).
We found this trial at
6
sites
2319 Highland Drive
Salt Lake City, Utah 84106
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Jacksonville, Florida 32256
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Jacksonville, FL
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Pickens, South Carolina 29671
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Pickens, SC
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Roanoke, Virginia 24153
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Roanoke, VA
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San Francisco, California 94110
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San Francisco, CA
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Vestal, New York 13850
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Vestal, NY
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