A Comparison of Two Daily Disposable Soft Contact Lenses



Status:Completed
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:18 - 39
Updated:6/21/2018
Start Date:March 2015
End Date:April 2015

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Approximately 120 subjects will be comparing two soft contact lenses for one week each.


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 be appear able and willing to adhere to instruction set forth in this
clinical protocol.

3. The subject be between (and including) 18 and 39 years of age.

4. The subject must be an adapted wearer of spherical soft contact lenses in both eyes.
That is, the subject must wear their habitual lenses at least five (5) days per week
and eight (8) hours per day worn for at least 30 days immediately preceding the study.

5. The subject's vertex corrected spherical equivalent distance refraction must be in the
range of -0.50 to -6.00 D in each eye.

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

Exclusion Criteria:

1. Currently pregnant or breastfeeding (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 autoimmune disease or use of any medication, which may interfere with contact lens
wear.

4. Entropoin, Ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of
recurrent corneal erosions, or aphakia.

5. Any previous, or planned ocular or intraocular surgery (e.g. radial keratotomy, 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
inflammatory event (e.g. past peripheral ulcer or round scar), or any other ocular
abnormality that may contraindicate contact lens wear.

7. Any ocular infection.

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

9. Monovision, multifocal, toric, or extended wear contact lens correction.

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

11. History of binocular vision abnormality or strabismus.

12. Any infectious disease (e.g. hepatitis, tuberculosis) or contagious immunosuppressive
disease (e.g. HIV) by self-report.
We found this trial at
6
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Jacksonville Beach, Florida 32250
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Montgomery, AL
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Salem, VA
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Winter Park, FL
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