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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-01

Study Completion Date

2017-03-21

Brief Summary

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

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Detailed Description

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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.

Conditions

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Astigmatism

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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enfilcon A (habitual)

All participants wear enfilcon A toric lens (habitual) and then refitted with fanfilcon A toric lenses.

Group Type NO_INTERVENTION

No interventions assigned to this group

fanfilcon A

All participants wear enfilcon A toric lens (habitual) and then refitted with fanfilcon A toric lenses.

Group Type ACTIVE_COMPARATOR

fanfilcon A

Intervention Type DEVICE

contact lens

Interventions

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fanfilcon A

contact lens

Intervention Type DEVICE

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes