Myopia
Conditions
Brief summary
The goal of this study is to compare the performance of two daily disposable silicone hydrogel lenses.
Detailed description
This study is prospective, bilateral eye, double masked, randomized, 1 week cross-over, daily wear design involving in two different daily disposable lens types. Each lens type will be worn for approximately one week.
Interventions
One week wear
DEVICETest Lens (senofilcon A)
One week wear
Sponsors
Centre for Ocular Research & Education, Canada
CooperVision, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
No
Inclusion criteria
* Is between 18 and 35 years of age (inclusively) 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; * Self-reports spending on most days at least 6 hours cumulative (not necessarily in one single stretch) using digital devices such as a computer, laptop, tablet, e-reader, smartphone; * 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; 1. No more than 1/3 of participants should be habitual wearer of MyDay or MyDay Energys 2. No more than 1/3 of participants should be habitual wearer of ACUVUE® OASYS MAX 1-Day or ACUVUE® OASYS 1-Day. * 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; * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lens Handling on Removal | Collected once on day 6 at the end of wear | Ease of lens removal on a 0-100 scale (0= very difficult, 100= very easy) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Analysis Population All participants who completed study. (Total study population n=68) | 68 |
| Total | 68 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Period 2 (1 Week) | Should not have been enrolled. Participant was nursing (lactating). | 0 | 1 |
Baseline characteristics
| Characteristic | Analysis Population | — |
|---|---|---|
| Age, Continuous | 27.7 Years STANDARD_DEVIATION 5.6 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 52 Participants | — |
| Sex: Female, Male Male | 16 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 69 | 0 / 69 |
| other Total, other adverse events | 1 / 69 | 1 / 69 |
| serious Total, serious adverse events | 0 / 69 | 0 / 69 |
Outcome results
Primary
Lens Handling on Removal
Ease of lens removal on a 0-100 scale (0= very difficult, 100= very easy)
Time frame: Collected once on day 6 at the end of wear
Population: Total Analysis Population is 68, only those who completed the study.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Control Lens | Lens Handling on Removal | 90 Units on a scale | Standard Deviation 18 |
| Test Lens | Lens Handling on Removal | 95 Units on a scale | Standard Deviation 8 |