Myopia
Conditions
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.
Interventions
DEVICEstenfilcon A - (Test lens)
Subjects will be randomized to wear test lenses for one week.
DEVICEkalifilcon A - (Control Lens)
Subjects will be randomized to wear control lenses for one week.
Sponsors
CooperVision, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Is at least 18 years of age and has full legal capacity to volunteer; 2. Has read and signed an information consent letter; 3. Self reports having a full eye examination in the previous two years; 4. Anticipates being able to wear the study lenses for at least 8 hours a day, 7 days a week; 5. Is willing and able to follow instructions and maintain the appointment schedule; 6. Habitually wears soft contact lenses, for the past 3 months minimum; 7. Has refractive astigmatism no higher than -0.75DC in each eye; 8. 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
1. Is participating in any concurrent clinical or research study; 2. Habitually wears one of the study contact lenses; 3. Has any known active\* ocular disease and/or infection that contraindicates contact lens wear; 4. Has a systemic condition that in the opinion of the investigator may affect a study outcome variable; 5. Is using any systemic or topical medications that in the opinion of the investigator may affect contact lens wear or a study outcome variable; 6. Has known sensitivity to the diagnostic sodium fluorescein used in the study; 7. Self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment; 8. Has undergone refractive error surgery or intraocular surgery.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lens Wettability | 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) |
Countries
United States
Participant flow
Pre-assignment details
68 participants were screened, 2 subjects discontinued, and 66 subjects were dispensed with the study lenses.
Participants by arm
| Arm | Count |
|---|---|
| Overall Study Subjects were 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) | 68 |
| Total | 68 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| First Intervention | Covid-19 related self-isolation | 0 | 1 |
| Second Intervention | Adverse Event | 0 | 1 |
Baseline characteristics
| Characteristic | Overall Study | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 68 Participants | — |
| Age, Continuous | 33.3 years STANDARD_DEVIATION 8.2 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 68 participants | — |
| Sex: Female, Male Female | 47 Participants | — |
| Sex: Female, Male Male | 21 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 66 | 0 / 66 |
| other Total, other adverse events | 1 / 66 | 0 / 66 |
| serious Total, serious adverse events | 0 / 66 | 0 / 66 |
Outcome results
Primary
Lens Wettability
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)
Time frame: Baseline - after 2 hours of lens wear
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stenfilcon A - (Test Lens) | Lens Wettability | 3.7 units on a scale | Standard Deviation 0.4 |
| Kalifilcon A - (Control Lens) | Lens Wettability | 3.7 units on a scale | Standard Deviation 0.5 |
Primary
Lens Wettability
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)
Time frame: 1 week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stenfilcon A - (Test Lens) | Lens Wettability | 3.5 units on a scale | Standard Deviation 0.6 |
| Kalifilcon A - (Control Lens) | Lens Wettability | 3.5 units on a scale | Standard Deviation 0.6 |