Clinical Evaluation of Two Monthly Replacement Silicone Hydrogel Contact Lenses



Status:Completed
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:18 - Any
Updated:11/30/2013
Start Date:May 2013
End Date:November 2013
Contact:Alcon Call Center
Email:alcon.medinfo@alcon.com
Phone:1-888-451-3937

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The purpose of this study is evaluate the performance at the end of the month for two
monthly replacement silicone hydrogel contact lenses.


Inclusion Criteria:

- Sign written Informed Consent Document and HIPAA form.

- Currently wearing sphere or toric soft contact lenses and has worn these lenses for
at least twelve (12) months, daily wear use only.

- Symptomatic for contact lens-related ocular discomfort.

- Current contact lens prescription within the available parameters of both study
products.

- Able to achieve visual acuity of at least 6/7.5 (20/25) in each eye with study lenses
in the available parameters.

- Willing to wear study lenses for at least 8 hours/day and at least 5 days/week for
the one month trial period.

- Willing and able to follow instructions and maintain the appointment schedule.

- Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

- Neophytes and current wearers of AIR OPTIX Aqua, AIR OPTIX NIGHT & DAY Aqua, AIR
OPTIX for Astigmatism, Biofinity sphere, Biofinity Toric, or ProClear Toric soft
contact lenses.

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

- Recent (within 7 days of enrollment) or current ocular infections, active ocular
inflammation, glaucoma or preauricular lymphadenopathy.

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

- Topical or systemic antibiotics use within 7 days of enrollment.

- Topical ocular or systemic corticosteroids use within 14 days of enrollment
continuing throughout the study.

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

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