CLEAR CARE® PLUS for Presbyopic Contact Lens Wearers



Status:Active, not recruiting
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:45 - 65
Updated:2/3/2017
Start Date:December 13, 2016
End Date:March 31, 2017

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Clinical Study of CLEAR CARE® PLUS for Presbyopic Contact Lens Wearers

The purpose of this study is to evaluate CLEAR CARE® PLUS (CCP) compared to non-HYDRAGLYDE®
multipurpose contact lens solutions in presbyopes currently wearing soft contact lenses and
experiencing symptoms of dryness.


Inclusion Criteria:

- Must sign an informed consent document;

- Current adapted two-week/monthly replacement soft contact lens wearers (at least 2
months) with symptoms of contact lens induced dryness;

- Near spectacle add of +0.50 or greater;

- Best corrected visual acuity (BCVA) to 20/30 or better in each eye at distance;

- Willing to wear lenses for a minimum of 5 days per week, 6 hours per day, and attend
all study visits;

- Currently (at least 2 months) using a non-HYDRAGLYDE® containing multi-purpose
solution (OPTI-FREE® PureMoist® is excluded) to care for lenses;

- Use of digital devices (eg, smart phone, tablet, laptop computer, or desktop
computer) for 20 consecutive minutes at least twice a week and willing to continue
the same pattern for the duration of the study;

- Other protocol-specific inclusion criteria may apply.

Exclusion Criteria:

- Extended wear contact lens wearer (sleeps in lenses 1 or more nights per week);

- Any anterior segment infection, inflammation, disease, or abnormality that
contraindicates contact lens wear as determined by the investigator;

- Any use of systemic or ocular medications for which contact lens wear could be
contraindicated, as determined by the investigator, including use of any topical
ocular medications that would require instillation during contact lens wear;

- Monocular (only 1 eye with functional vision) or fit with only 1 lens;

- Known sensitivity to any ingredients in CCP;

- Prior refractive surgery;

- History of herpetic keratitis, ocular surgery, or irregular cornea;

- Pathological dry eye that precludes contact lens wear;

- Use of mechanical eyelid therapy or eyelid scrubs within 14 days before Visit 1 and
not willing to discontinue during the study;

- Participation in any clinical study within 30 days of Visit 1;

- Currently using or have not discontinued Restasis®, Xiidra® or a topical steroid
within the past 7 days;

- Other protocol-specific exclusion criteria may apply.
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