Multi-Center Clinical Evaluation of Two Reusable Soft Contact Lenses



Status:Completed
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:18 - 50
Updated:10/26/2017
Start Date:August 2015
End Date:March 2016

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The purpose of this study is to compare the subjective performance of comfilcon A lens
against samfilcon A lens after 4 weeks of reusable lens wear.

This will be a 90 subject, randomized, bilateral, subject-masked, dispensing, cross-over
study comparing comfilcon A versus samfilcon A lenses over 8 weeks of daily wear (2 x
4-weeks). Both eyes will wear the same lens (test or control) for 4 weeks in a randomized
fashion. Subjects will be masked to lens type and investigators will be masked to the lens
codes.

Inclusion:

- Spherical distance Contact Lens prescription between -1.00 and -6.00D or +1.00 to
+4.00D in both eyes (inclusive)

- Adapted soft Contact Lens wearers (i.e. >1 month), daily disposable and reusable lens
wearers.

- Spectacle cylinder 0.75D in both eyes.

- Correctable to 6/9 (20/30) in both eyes

- Be between 18 and 50 years of age (inclusive)

- Able to read, comprehend and sign an informed consent

- Own a mobile phone and be willing to respond to Short Message Service (SMS) survey

- Willing to comply with the wear and study visit schedule

Exclusion:

- Existing Biofinity or Ultra wearers

- Any active corneal infection, injury or inflammation

- Systemic or ocular allergies, which might interfere with Contact Lens wear

- Systemic disease, which might interfere with Contact Lens wear

- Ocular disease, which might interfere with Contact Lens wear

- Strabismus or amblyopia

- Subjects who have undergone corneal refractive surgery

- Subjects with keratoconus or other severe corneal irregularity contraindicating lens
wear

- Pregnant or lactating

- Use of systemic/topical medication contraindicating Contact Lens wear

- Diabetic

- Site employees or family members of site employees
We found this trial at
3
sites
Whittier, California 90606
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Whittier, CA
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Chew Magna, Bristol
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Chew Magna,
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Medina, Minnesota 55340
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Medina, MN
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