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 |
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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