Evaluation of the Effectiveness of Two Marketed Multi-Purpose Solutions for Silicone Hydrogel Contact Lenses - Study 2



Status:Completed
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:Any
Updated:2/4/2013
Start Date:November 2012
End Date:March 2013
Contact:Alcon Call Center
Phone:1-888-451-3937

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The purpose of this study is to compare clinical and comfort outcomes of two marketed
multi-purpose contact lens solutions.


Inclusion Criteria:

- Wear single vision sphere silicone hydrogel contact lenses (CooperVision™ Biofinity®,
Alcon® Air Optix® Aqua, Bausch+Lomb® PureVision™ or ACUVUE® Oasys™) on a daily wear
basis (a minimum of 8 hours per day, 5 days a week) for at least one month prior to
Visit 1;

- Willing to wear lenses on a daily wear basis (a minimum of 8 hours per day, 5 days a
week) for the duration of the study, and wear lenses for 16 hours on two days during
the study;

- Must have habitually used a Biguanide preserved multi-purpose solution (other than
RevitaLens) for at least 30 days prior to Visit 1;

- Vision correctable to 20/30 Snellen (feet) or better in each eye at distance with
pre-study contact lenses at Visit 1;

- Have access, capability and willingness to review and answer text messages;

- Read, sign, and date IRB/IEC approved informed consent and privacy document before
enrollment;

- Willing to follow the study procedures and visit schedule;

- Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

- Need to wear lenses on an extended wear (i.e overnight) basis during the study;

- Known sensitivity or intolerance to Biguanide, polyquaternium-1 (POLYQUAD), Alexidine
or ALDOX preserved lens care products;

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

- Wearing toric or multifocal contact lenses or fit with monovision;

- Use of additional lens care products other than a Biguanide preserved multipurpose
solution such as daily or enzyme cleaners within the one week prior to Visit 1;

- Use of topical ocular over-the-counter (OTC) or prescribed topical ocular
medications, with the exception of rewetting drops, within 7 days prior to Visit 1;

- Abnormal ocular condition observed during the Visit 1 slit-lamp examination;

- Current or history of ocular infections or severe inflammation within 6 months prior
to Visit 1;

- Ocular surgery within the 12 months prior to Visit 1;

- Participation in any other clinical trial within 30 days of enrollment;

- Other protocol-defined exclusion criteria may apply.
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