Evaluation of the Performance of Different Daily Disposable Lens Designs in Habitual Soft Contact Lens Wearers

Not Applicable

Completed

Interventions: Device: stenfilcon A - (Test lens)
Device: kalifilcon A - (Control Lens)

Brief Summary: The main objective of the study is to refit existing soft lens wearers with two different daily disposable contact lens types, Lens A and Lens B, to determine their performance after one week of wear.

Detailed Description: This study is a prospective, bilateral eye, double-masked, randomized, 1-week cross-over, daily-wear design involving two different daily disposable lens types. Each lens type will be worn for approximately one week, during which participants record their subjective lens-wear experience.

Recruitment & Eligibility

Inclusion Criteria

Is at least 18 years of age and has full legal capacity to volunteer;
Has read and signed an information consent letter;
Self reports having a full eye examination in the previous two years;
Anticipates being able to wear the study lenses for at least 8 hours a day, 7 days a week;
Is willing and able to follow instructions and maintain the appointment schedule;
Habitually wears soft contact lenses, for the past 3 months minimum;
Has refractive astigmatism no higher than -0.75DC in each eye;
Can be fit and achieve binocular distance vision of at least 20/30 Snellen (Available lens parameters are sphere -1.00 to -6.00D, 0.25D steps).

Exclusion Criteria

Is participating in any concurrent clinical or research study;
Habitually wears one of the study contact lenses;
Has any known active* ocular disease and/or infection that contraindicates contact lens wear;
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 contact lens wear or a study outcome variable;
Has known sensitivity to the diagnostic sodium fluorescein used in the study;
Self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment;
Has undergone refractive error surgery or intraocular surgery.

Arm && Interventions

Group	Intervention	Description
kalifilcon A - (Control Lens)	stenfilcon A - (Test lens)	Subjects will be randomized to wear control lenses for one week then cross-over to the test lenses for one week.
kalifilcon A - (Control Lens)	kalifilcon A - (Control Lens)	Subjects will be randomized to wear control lenses for one week then cross-over to the test lenses for one week.
stenfilcon A - (Test lens)	stenfilcon A - (Test lens)	Subjects will be randomized to wear test lenses for one week then cross-over to the control lenses for one week.
stenfilcon A - (Test lens)	kalifilcon A - (Control Lens)	Subjects will be randomized to wear test lenses for one week then cross-over to the control lenses for one week.

Primary Outcome Measures

Name	Time	Method
Lens Wettability	1 week	Lens wettability on a 0 to 4 descriptive scale, 0.5 steps (0 - Very poor: Immediately displaying non-wetting areas on the lens surface, immediate drying time, 1 - Poor: Irregular surface appearance, drying time \<\< blink time, 2 - Acceptable: Smooth surface appearance immediately after the blink becoming irregular after a while, drying time ≤ blink time, 3 - Good: Typical soft lens appearance with long drying time, 4 - Excellent: Appearance similar to a healthy cornea with very long drying time)

Secondary Outcome Measures

Name	Time	Method

Locations (4): Complete Eye Care of Medina
🇺🇸
Medina, Minnesota, United States
Athens Eye Care
🇺🇸
Athens, Ohio, United States
Nittany Eye Associates
🇺🇸
College, Pennsylvania, United States
Sacco Eye Group, PLLC
🇺🇸
Vestal, New York, United States