Comparison of Two Daily Disposable Soft Contact Lenses

Not Applicable

Completed

Brief Summary: The aim of this study was to investigate the short-term clinical performance and subjective acceptance of the two study lenses.

Detailed Description: This study was a randomised, double-masked, crossover, bilateral dispensing study, controlled by cross-comparison. Fifty-five subjects will wear each lens brand for approximately one week in random order. Lenses were worn on a daily wear, daily disposable basis.

Recruitment & Eligibility

Inclusion Criteria

They are between 18 and 40 years of age (inclusive).
They understand their rights as a research subject and are willing to sign a Statement of Informed Consent.
They are willing and able to follow the protocol.
They are an existing silicone hydrogel reusable spherical contact lens wearer in both eyes.
They have a contact lens spherical prescription between -0.25D and -6.00D (inclusive) based on ocular refraction.
They own a wearable pair of spectacles and wear them on the day of the initial visit.
At dispensing, they can attain at least 0.20 logMAR distance high contrast visual acuity in each eye with the study lenses within the available power range.
They are willing to comply with the wear schedule (at least five days per week and for at least eight hours per day).
They agree not to participate in other clinical research for the duration of the study.

Exclusion Criteria

They have an ocular disorder, which would normally contra-indicate contact lens wear.
They have a systemic disorder, which would normally contra-indicate contact lens wear.
They are using any topical medication such as eye drops or ointment, or use any rewetting/lubricating drops whilst on this study.
They are aphakic.
They have had corneal refractive surgery.
They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
They are pregnant or breastfeeding.
They have any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear
They have any infectious disease which would, in the opinion of the investigator, contraindicate contact lens wear or pose a risk to study personnel; or they have any immunosuppressive disease (e.g. HIV), or a history of anaphylaxis or severe allergic reaction.
They have taken part in any contact lens or care system clinical research within two weeks prior to starting this study.

Arm && Interventions

Group	Intervention	Description
midafilcon A	midafilcon A	Subjects will be randomized to wear midafilcon A 1 day for one week of daily wear during the study.
somofilcon A	somofilcon A	Subjects will be randomized to wear somofilcon A 1 day for one week of daily wear during the study.

Primary Outcome Measures

Name	Time	Method
Lens Fit - Corneal Coverage	One Week	Assessment of corneal coverage of lens (extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive)
Lens Fit - Lens Movement	One Week	Lens movement assessed per corneal coverage (extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive)
Lens Fit - Horizontal Centration	One Week	Assessment of horizontal centration of lens (extremely nasal, slightly nasal, optimum, slightly temporal, extremely temporal)
Lens Fit - Vertical Centration	One Week	Assessment of vertical centration of lens (extremely inferior, slightly inferior, optimum, slightly superior, extremely superior)

Secondary Outcome Measures

Name	Time	Method
Subjective Score for Vision	One week	Subjects will score on visual analogue scale for Vision (0 -100) (0 - Unacceptable, 20 - Very poor, 40 - Poor, 60 - Good, 80 - Very Good, 100 - Excellent)