Multi-center Clinical Evaluation of PC 1-Day vs 1-Day Acuvue Moist



Status:Completed
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:18 - 40
Updated:4/21/2016
Start Date:January 2014
End Date:March 2014

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The objective of this study is to compare the clinical performance of ProClear 1-Day versus
1-Day Acuvue Moist each for one week of daily disposable wear.

The purpose of this cross-over study is to evaluate the clinical performance of the
ProClear-1 Day in comparison with 1-Day Acuvue® Moist®. In particular, the study will focus
on lens wearing comfort.

Inclusion Criteria:

A person is eligible for inclusion in the study if he/she:

- Is between 18 and 40 years of age (inclusive)

- Have the use of a mobile phone to send and receive text messages throughout the day
for the duration of the study.

- Has had a self-reported visual exam in the last two years

- Is an adapted soft CL (Contact Lens) wearer

- Must be able to wear their lenses at least 6 full days over the 7 days; 14 hours per
day, assuming there are no contraindications for doing so

- Has a CL spherical prescription between - 1.00 and - 6.00 (inclusive)

- Has less than 0.75D (Diopters) spectacle cylinder in each eye.

- Is correctable to a visual acuity of 20/25 or better in both eyes

- Has clear corneas and no active ocular disease

- Has read, understood and signed the information consent letter.

- Is willing to comply with the wear schedule (at least 40 hrs per week)

- Is willing to comply with the visit schedule

Exclusion Criteria:

A person will be excluded from the study if he/she:

- Has never worn contact lenses before.

- Currently wears rigid gas permeable contact lenses.

- Has a history of not achieving comfortable CL wear (5 days per week; > 8 hours/day)

- Has a CL prescription outside the range of - 1.00 to -6.00D

- Has a spectacle cylinder greater than -0.50D of cylinder in either eye.

- Has best corrected spectacle distance vision worse then 20/25 in either eye.

- Has any systemic disease affecting ocular health.

- Is using any systemic or topical medications that will affect ocular health.

- Has any ocular pathology or severe insufficiency of lacrimal secretion

- Has persistent, clinically significant corneal or conjunctival staining

- Has active neovascularization or any central corneal scars.

- Is aphakic.

- Is presbyopic.

- Has undergone corneal refractive surgery.

- Is participating in any other type of eye related clinical or research study.
We found this trial at
4
sites
Phoenix, Arizona 85032
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Phoenix, AZ
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Athens, Ohio 45701
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Athens, OH
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Lake Zurich, Illinois 60047
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Lake Zurich, IL
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New Albany, Ohio 43054
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New Albany, OH
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