Clinical Evaluation of Stenfilcon A Contact Lenses

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-03

Study Completion Date

2018-04-25

Brief Summary

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This study is to evaluate the fitting performance of stenfilcon A contact lens (test) compared to narafilcon A contact lens (control).

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Detailed Description

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This study is to evaluate the fitting performance of stenfilcon A contact lens (test) compared to narafilcon A contact lens (control) over 3 hour of wear time in a Japanese population.

Conditions

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Myopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This will be a non-dispensing, randomized, contralateral study comparing a test lens against the appropriate control lens.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Each subject will be masked as to which lens is worn on each eye.

Study Groups

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stenfilcon A lens

MyDay contact lens

Group Type EXPERIMENTAL

stenfilcon A lens

Intervention Type DEVICE

contact lens

narafilcon A lens

1-Day Acuvue TruEye

Group Type ACTIVE_COMPARATOR

narafilcon A lens

Intervention Type DEVICE

contact lens

Interventions

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stenfilcon A lens

contact lens

Intervention Type DEVICE

narafilcon A lens

contact lens

Intervention Type DEVICE

Other Intervention Names

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MyDay, test 1-day Acuvue TruEye, control

Eligibility Criteria

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Inclusion Criteria

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

* Is Japanese
* Has had a self-reported oculo-visual examination in the last two years.
* Is at least 18 years of age and has full legal capacity to volunteer.
* Has read and understood the informed consent letter.
* Is willing and able to follow instructions and maintain the appointment schedule.
* Is correctable to a visual acuity of 20/40 or better (in each eye) with their habitual vision correction or 20/20 best-corrected.
* Currently wears soft contact lenses.
* Has clear corneas and no active ocular disease.

Exclusion Criteria

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

* Has never worn contact lenses before.
* Has any systemic disease affecting ocular health.
* Is using any systemic or topical medications that will affect ocular health.
* Has any ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses.
* Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye.
* Has any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars.
* Is aphakic.
* Has undergone corneal refractive surgery.
* Is participating in any other type of eye related clinical or research study.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No