Performance Comparison Between Comfilcon A and Senofilcon C Lenses



Status:Completed
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:18 - 34
Updated:1/11/2018
Start Date:September 2016
End Date:November 23, 2016

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The aim of this study is to determine the clinical performance of comfilcon A in comparison
to senofilcon C.

This is a prospective, multi-center, bilateral, double-masked, randomized, cross-over, daily
wear, two month dispensing study comparing the clinical performance of comfilcon A and
senofilcon C lenses after one month of wear.

Inclusion Criteria:

A person is eligible for inclusion in the study if he/she:

- Is between 18 and 34 years of age (inclusive)

- Has had a self-reported eye exam in the last two years

- Is a spherical soft contact lens wearer

- Has a contact lens spherical prescription between -1.00 to -6.00 (inclusive)

- Has a spectacle cylinder no greater than 0.75D (Diopters) in each eye.

- Can achieve best corrected spectacle distance visual acuity of 20/25 (0.10 logMAR) or
better in each eye.

- Can achieve a distance visual acuity of 20/30 (0.18 logMAR) or better in each eye with
the study contact lenses.

- Has clear corneas and no active ocular disease

- Has read, understood and signed the information consent letter.

- Has a contact lens prescription that fits within the available parameters of the study
lenses.

- Is willing and anticipated to be able to comply with the wear schedule (at least 6
days per week, 12 hours/day assuming there are no contraindications for doing so).

- Is willing to comply with the visit schedule

Exclusion Criteria:

A person will be excluded from the study if he/she:

- Has a history of not achieving comfortable CL (contact lens) wear (defined as 6 days
per week; > 10 hours/day)

- Presents with clinically significant anterior segment abnormalities

- Presents with ocular or systemic disease or need of medications which might interfere
with contact lens wear.

- Presents with slit lamp findings that would contraindicate contact lens wear such as:

- Pathological dry eye or associated findings

- Significant pterygium, pinguecula, or corneal scars within the visual axis

- Neovascularization > 0.75 mm in from of the limbus

- Giant papillary conjunctivitis (GCP) worse than grade 1

- Anterior uveitis or iritis (or history in past year)

- Seborrheic eczema of eyelid region, Seborrheic conjunctivitis

- History of corneal ulcers or fungal infections

- Poor personal hygiene

- Has a known history of corneal hypoesthesia (reduced corneal sensitivity)

- Has aphakia, keratoconus or a highly irregular cornea.

- Has presbyopia or has dependence on spectacles for near work over the contact lenses.

- Has undergone corneal refractive surgery.

- Is participating in any other type of eye related clinical or research study.

- Is habitually using rewetting/ lubricating eye drops more than once per day

- Is currently wearing daily disposable lenses
We found this trial at
5
sites
New Albany, Ohio 43054
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New Albany, OH
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5201 Eden Avenue
Edina, Minnesota 55436
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Edina, MN
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10101 West Colonial Drive
Ocoee, Florida 34761
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Ocoee, FL
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Vestal, New York 13850
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Vestal, NY
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Whittier, California 90606
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Whittier, CA
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