A 6-Hour Clinical Evaluation of New Daily-Wear Soft Contact 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

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-25

Study Completion Date

2017-08-03

Brief Summary

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The purpose of this study is to validate the clinical performance of a new contact lens design when worn over a period of 6 hours compared to nelfilcon A (control).

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Detailed Description

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The purpose of this study is to validate the clinical performance of a new contact lens design when worn over a period of 6 hours compared to nelfilcon A (control). The primary outcomes of interest are lens fit and lens fit preference.

Conditions

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Myopia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

This will be a non-dispensing, double-masked, contralateral study comparing test contact lens against a nelfilcon A control lens. Subjects will be randomized to wear the test lens in one eye and the control lens in the other. It is anticipated that this study will involve up to 2 scheduled visits, at Baseline (BL) and 6 hours.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Both subject and investigator will be masked to lens type for each eye. A different investigator will select the study lenses for insertion by the subject, from those performing the assessments in order to maintain masking.

Study Groups

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Test lens

Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule (to determine which eye receives test/control lens).

Group Type ACTIVE_COMPARATOR

Test Lens

Intervention Type DEVICE

Daily disposable contact lens

Control Lens

Intervention Type DEVICE

Focus Dailies All Day Comfort contact lens (nelfilcon A)

nelfilcon A lens (control)

Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule (to determine which eye receives test/control lens).

Group Type ACTIVE_COMPARATOR

Test Lens

Intervention Type DEVICE

Daily disposable contact lens

Control Lens

Intervention Type DEVICE

Focus Dailies All Day Comfort contact lens (nelfilcon A)

Interventions

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Test Lens

Daily disposable contact lens

Intervention Type DEVICE

Control Lens

Focus Dailies All Day Comfort contact lens (nelfilcon A)

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Is at least 18 years of age and has full legal capacity to volunteer
* Has read, fully understood and signed the information consent letter
* Currently wears or has previously worn soft contact lenses
* Has spectacle cylinder ≤1.00D in both eyes.
* Has spherical contact lens power requirement between -1.00D and -6.00D in both eyes.
* Has manifest refraction visual acuities (VA) equal to or better than logMAR equivalent of 20/25 in each eye.
* Has clear corneas and no active ocular disease
* Is willing and able to follow product usage instructions and maintain the visit schedule.

Exclusion Criteria

* Has never worn contact lenses before
* Has a systemic condition that in the opinion of the investigator may affect a study outcome variable
* Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable
* Has any known active ocular disease and/or infection
* Has a monovision correction
* Has any ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses
* Is aphakic
* Has undergone corneal refractive surgery
* Is pregnant or lactating, determined by self-report

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No