Astigmatism
Conditions
Brief summary
The objective of the study is to compare the clinical performance of two different daily disposable, SiHy toric contact lens types, Lens A and Lens B, in existing soft lens wearers when worn for one week each.
Detailed description
This study is a prospective, bilateral eye, double-masked, randomized, 1-week cross-over, daily-wear design involving two different daily disposable toric lens types. Each lens type will be worn for approximately one week, during which participants record their subjective lens-wear experience.
Interventions
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
* 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 12 hours a day, 7 days a week; * Is willing and able to follow instructions and maintain the appointment schedule; * Habitually wears toric soft contact lenses binocularly, of any replacement frequency, for the past 3 months minimum; * Has refractive astigmatism at least -0.75DC in each eye, maximum -2.25DC; * Has refractive cylinder axis either between 155 to 25 or between 65 and 115 degrees; * Is myopic and requires a spectacle spherical component of -1.00D to -6.50D inclusively; * Can be fit and achieve binocular distance vision of at least 20/30 Snellen with the available lens parameters
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Ease of Lens Handling | 1 week | Ease of overall lens handling for putting on eyes, removing from eyes, and opening packaging will be measured on a 0-10 integer scale (0=Very difficult, 10-Very easy) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Acuity | Baseline - after lenses have settled for 10 minutes | Visual acuity will be measured using LogMAR scale in high room illumination high contrast: distance (≥4m) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Overall Study daily disposable soft contact lens - test lens
Subjects will be randomized to wear test lenses for one week and then cross-over to control lenses for one week.
Lens A: daily disposable soft contact lens - test lens
Lens B: daily disposable soft contact lens - control lens | 48 |
| Total | 48 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| First 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 | 48 Participants | — |
| Age, Continuous | 32.5 years STANDARD_DEVIATION 6.8 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 48 participants | — |
| Sex: Female, Male Female | 34 Participants | — |
| Sex: Female, Male Male | 14 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 48 | 0 / 48 |
| other Total, other adverse events | 0 / 48 | 1 / 48 |
| serious Total, serious adverse events | 0 / 48 | 0 / 48 |
Outcome results
Primary
Overall Ease of Lens Handling
Ease of overall lens handling for putting on eyes, removing from eyes, and opening packaging will be measured on a 0-10 integer scale (0=Very difficult, 10-Very easy)
Time frame: 1 week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lens A | Overall Ease of Lens Handling | 9.0 units on a scale | Standard Deviation 1.1 |
| Lens B | Overall Ease of Lens Handling | 8.8 units on a scale | Standard Deviation 1.5 |
Secondary
Visual Acuity
Visual acuity will be measured using LogMAR scale in high room illumination high contrast: distance (≥4m)
Time frame: Baseline - after lenses have settled for 10 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lens A | Visual Acuity | -0.06 logMAR | Standard Deviation 0.06 |
| Lens B | Visual Acuity | -0.06 logMAR | Standard Deviation 0.06 |
Secondary
Visual Acuity
Visual acuity will be measured using LogMAR scale in high room illumination high contrast: distance (≥4m)
Time frame: 1 week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lens A | Visual Acuity | -0.06 logMAR | Standard Deviation 0.06 |
| Lens B | Visual Acuity | -0.05 logMAR | Standard Deviation 0.06 |