Performance of Fanfilcon A Toric Lenses After at Least One Month Wearing Enfilcon A Toric Lenses



Status:Completed
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:18 - 40
Updated:4/17/2018
Start Date:October 1, 2016
End Date:March 21, 2017

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This is a prospective, multi-center, subject-masked, bilateral, daily wear, two-month
dispensing study

The aim of this study is to determine if adapted contact lens wearers enfilcon A toric lenses
can be confidently refit into fanfilcon A toric lenses and can be successful after one month
of daily wear.

Inclusion Criteria:

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

- Is between 18 and 40 years of age (inclusive)

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

- Is a habitual soft toric lens wearer

- Can be successfully fit with study lenses (≥ grade 2 fit acceptance)

- Has a contact lens spherical prescription between -1.00 to -6.00D with a cylinder
between -0.75 and -1.75D (Diopters) (inclusive)

- Has a spectacle cylinder of at least 0.75D in each eye.

- Can achieve best corrected spectacle refraction 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 refraction that fits within the available parameters of the study
lenses

- Is willing to comply with the wear schedule (at least 5 days per week, > 8 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 (5 days per week; >
8 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

- 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 frequently using rewetting/ lubricating eye drops (more than once per day)
We found this trial at
4
sites
900 Northwest 17th Street
Miami, Florida 33136
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Miami, FL
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520 Durie Avenue
CLoster, New Jersey 07624
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CLoster, NJ
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10 Sheridan Square
New York, New York 10014
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New York, NY
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Spokane, Washington 99204
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Spokane, WA
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