Evaluation of the Performance of Different Daily Disposable Lens Designs in Habitual Soft Contact Lens Wearers
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Coopervision, Inc.
- Enrollment
- 68
- Locations
- 4
- Primary Endpoint
- Lens Wettability
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
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.
Intervention: stenfilcon A - (Test lens) (Device)
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.
Intervention: kalifilcon A - (Control Lens) (Device)
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.
Intervention: stenfilcon A - (Test lens) (Device)
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.
Intervention: kalifilcon A - (Control Lens) (Device)
Outcomes
Primary Outcomes
Lens Wettability
Time Frame: 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)
Lens Wettability
Time Frame: Baseline - after 2 hours of lens wear
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 Outcomes
No secondary outcomes reported