Daily Disposable Dispensing Clinical Trial of Test Lens Against Stenfilcon A Lens

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2017-06-26

Brief Summary

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The purpose of this study is to investigate the overall clinical performance of the test daily disposable stenfilcon A lens with solution additive (test) compared to the stenfilcon A lens (control).

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Detailed Description

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This will be, prospective, multicenter, double-masked, randomized, bilateral, 1 month cross-over, dispensing study comparing the test lens against the stenfilcon A control lens with a study duration of approximately two months.

Each subject will be randomized to wear either the test or control as a matched pair first and subjects will be randomized based on the order in which the subject is enrolled and qualified into the study.

Conditions

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Myopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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stenfilcon A lens with solution additive (test)

Participants were randomized to wear the stenfilcon A lens with solution additive (test) for 1 month during the cross over study.

Group Type EXPERIMENTAL

stenfilcon A lens with solution additive (test)

Intervention Type DEVICE

silicone hydrogel lens

stenfilcon A lens (control)

Intervention Type DEVICE

contact lens

stenfilcon A lens (control)

Participants were randomized to wear stenfilcon A (control) lens pair for 1 month during the cross over study.

Group Type ACTIVE_COMPARATOR

stenfilcon A lens with solution additive (test)

Intervention Type DEVICE

silicone hydrogel lens

stenfilcon A lens (control)

Intervention Type DEVICE

contact lens

Interventions

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stenfilcon A lens with solution additive (test)

silicone hydrogel lens

Intervention Type DEVICE

stenfilcon A lens (control)

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:

* 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 information 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.
* Must achieve 20/30 or better (in each eye) with study lenses
* Requires spectacle lens powers between -0.75 and -6.50 diopters sphere (0.25D steps).
* Has no more than 0.75 diopters of refractive astigmatism.
* Currently wears soft contact lenses.
* Have clear corneas and no active ocular disease.
* Has not worn lenses for at least 12 hours before the examination

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 pregnant, lactating, or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit).
* Have taken part in any other contact lens or care solution clinical trial or research, within one week prior to starting this study.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes