Effectiveness of a Marketed One-Step Peroxide Lens Care Solution in Symptomatic Contact Lens Wearers



Status:Completed
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:18 - Any
Updated:5/5/2014
Start Date:December 2013
End Date:May 2014
Contact:Alcon Call Center
Email:alcon.medinfo@alcon.com
Phone:1-888-451-3937

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The purpose of this study is to assess improvement of palpebral roughness and associated
symptoms with 3 months use of Clear Care®.


Inclusion Criteria:

- Current biweekly or monthly silicone hydrogel contact lens wearer (excluding Air
Optix® brand) and have worn these lenses bilaterally for at least three (3) months
prior to Visit 1 (daily wear use only).

- Vision correctable to 20/30 Snellen (feet) or better in each eye at distance.

- Willing to wear study lenses on a daily wear schedule for at least 5 days a week and
a minimum of 6 hours on these days, and attend all study visits.

- Symptoms of contact lens discomfort as defined by the protocol.

- Habitual use of a biguanide-preserved multi-purpose solution for at least 30 days
prior to Visit 1.

- Mild to severe (grade 2-4) Investigator rated palpebral roughness in one or more
zones of either eye.

- Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

- Extended (over-night) contact lens wearer.

- Any systemic or ocular disease or disorder (refractive disorder allowed and mild dry
eye with successful contact lens wear is permitted), complicating factors or
structural abnormality that would negatively affect the conduct or outcome of the
study.

- History of ocular surgery/trauma within the last 6 months.

- Topical ocular over the counter (OTC) or prescribed medications, with the exception
of contact lens rewetting drops, within 7 days of enrollment.

- Systemic medications which have known or expected ocular or systemic side effects
(i.e., antihistamines, dermatologic agents, or antidepressants), that in the clinical
judgment of the Investigator, could affect the subject's participation in this study
unless they have been on a stable dosing regimen for a minimum of 30 days prior to
Visit 1.

- Unwilling to discontinue mechanical eyelid therapy or eyelid scrubs within 14 days of
enrollment and continuing during the study.

- Use of rewetting drops during the study other than Bausch and Lomb Sensitive Eyes®
Rewetting Drops.

- Participation in any other ophthalmic drug or device clinical trial within 30 days of
enrollment.

- Other protocol-specified exclusion criteria may apply.
We found this trial at
1
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6201 South Freeway
Fort Worth, Texas 76134
800 862 5266
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