A One-Week Crossover Dispensing Evaluation of New Daily Wear Soft Contact Lenses

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-28

Study Completion Date

2017-08-31

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 1 week 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 1 week compared to nelfilcon A (control). The primary outcomes of interest is lens fit acceptance.

Conditions

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Myopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

This will be a double-masked, bilateral, 1-week crossover, dispensing study, comparing the test daily wear lens against nelfilcon A control lens, such that each lens type will be worn for 1 week each. Each subject will be randomized to wear either the test lenses or the control lenses as a matched pair.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

The contact lenses coding will be masked to both the investigator and subject. If standard labeling does not sufficiently mask the study material then over-labeling will be performed.

Study Groups

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Test Contact Lens

Per randomized schedule, subject will wear a pair of the test lens or control lens for one week and then cross-over with the control pair for 1 week.

Group Type ACTIVE_COMPARATOR

Test Contact Lens

Intervention Type DEVICE

Daily disposable contact lens

Nelfilcon A

Intervention Type DEVICE

Focus Dailies All Day Comfort contact lens (nelfilcon A)

nelfilcon A lens (control)

Per randomized schedule, subject will wear a pair of the control lens for one week and then cross-over with the test pair for 1 week.

Group Type ACTIVE_COMPARATOR

Test Contact Lens

Intervention Type DEVICE

Daily disposable contact lens

Nelfilcon A

Intervention Type DEVICE

Focus Dailies All Day Comfort contact lens (nelfilcon A)

Interventions

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Test Contact Lens

Daily disposable contact lens

Intervention Type DEVICE

Nelfilcon A

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.
* Is no greater than 55 years of age.
* Has read and understood the information consent letter.
* Is willing and able to follow instructions and maintain the appointment schedule.
* Is an adapted soft contact lens wearer having worn lenses for a minimum of 4 weeks prior to the study.
* 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.
* Wears CLs in both eyes (monvision acceptable, but not monofit)
* Has clear corneas and no active ocular disease.
* Has not worn lenses for at least 12 hours before the examination.
* Is willing to wear the study contact lenses for a minimum 8 hours per day/6 days per week

Exclusion Criteria

* 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 strabismus/amblyopia.
* Has undergone corneal refractive surgery.
* Is pregnant, lactating or planning a pregnancy.
* Is participating in any concurrent clinical or research study.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No