Myopia
Conditions
Brief summary
The aim of this study is to determine if habitual or adapted wearers of stenfilcon A control contact lenses can be refit into test lenses and be successful after one week of daily wear.
Detailed description
This study is a prospective, multi-center, open label, bilateral, daily wear, one week dispensing study comparing performance of wearers of stenfilcon A control contact lenses after refit with test contact lenses.
Interventions
DEVICETest lens
contact lens
DEVICEcontrol lens
contact lens
Sponsors
CooperVision, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
No
Inclusion criteria
A person is eligible for inclusion in the study if he/she: * Is between 18 and 35 years of age (inclusive) * Has read and signed the informed consent letter * Is willing and anticipated to follow instructions and maintain the appointment schedule * Habitually wears soft spherical contact lenses with a power between -1.00D to -6.00D (inclusive) for a minimum 5 days per week, 10 hours per day and anticipates no difficulty wearing contact lenses for 7 days per week, 10 hours per day. * Habitually wears or is able to be adequately refit into MyDay Sphere lenses * Demonstrates an acceptable fit with the study lenses * Is correctable to a distance visual acuity of 0.20 logMAR (approximately 20/30) or better (in each eye) with the study contact lenses * Uses digital devices, (e.g. computer, tablet, smart phone, iPad), for more than 4 hours a day, 5 days a week. * Manifest cylindrical spectacle refraction does not exceed -0.75DC in either eye * Has clear corneas and no active ocular disease * Has a contact lens refraction that fits within the available parameters of the study lenses.
Exclusion criteria
A person will be excluded from the study if he/she: * Is participating in any concurrent clinical research study * Has a history of not achieving comfortable CL wear (5 days per week; \> 8 hours/day) * Has a systemic condition that, in the opinion of the investigator, may affect the study measures * Is using any systemic or topical medications that in the opinion of the investigator may affect the study measures. * Presents with slit lamp findings or clinically significant anterior segment abnormalities that would contraindicate contact lens wear such as: * Pathological dry eye or associated findings * Significant pterygium, pinguecula, or corneal scars within the visual axis * Neovascularization \> 0.75 mm in from of the limbus * Giant papillary conjunctivitis (GCP) worse than grade 1 * Anterior uveitis or iritis (or history in past year) * Seborrheic eczema of eyelid region, Seborrheic conjunctivitis * History of corneal ulcers or fungal infections * Poor personal hygiene * Has a known history of corneal hypoesthesia (reduced corneal sensitivity) * Has a known sensitivity to the diagnostic pharmaceuticals to be used in the study * Has aphakia, keratoconus or a highly irregular cornea. * Has presbyopia or has dependence on spectacles for near work over the contact lenses. * Has undergone refractive surgery. * Is pregnant, lactating or planning a pregnancy (by verbal communication) at the time of enrollment * Has participated in any other type of eye related clinical or research study within the last 7 days * Is habitually using rewetting/ lubricating eye drops (more than once per day)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Lens Fit Acceptance | Baseline (After 10 minutes of lens dispense) | Overall lens fit acceptance on a scale of 0-4, 0.5 steps (Scale: 0=should not be worn, 4=perfect) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lens Centration | Baseline - After 10 minutes of lens dispense | Lens centration was assessed on a 3 point scale (1-Optimum, 2- Decentration acceptable, 3-Decentration unacceptable) |
| Post-blink Movement | Baseline (after 10 minutes of lens dispense) | Post-blink movement assessed on a scale of 0-4, 1 step size (Scale: 0=Insufficient, 1=Minimal, 2=Optimal, 3=Moderate, 4=Excessive) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Overall Study All subjects will first wear stenfilcon A contact lenses for one week, then refitted with test contact lenses to wear for one week.
Test lens: contact lens
control lens: contact lens | 77 |
| Total | 77 |
Baseline characteristics
| Characteristic | Overall Study | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 77 Participants | — |
| Age, Continuous | 27.9 years STANDARD_DEVIATION 5.1 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 77 participants | — |
| Sex: Female, Male Female | 57 Participants | — |
| Sex: Female, Male Male | 20 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 77 | 0 / 77 |
| other Total, other adverse events | 0 / 77 | 0 / 77 |
| serious Total, serious adverse events | 0 / 77 | 0 / 77 |
Outcome results
Primary
Overall Lens Fit Acceptance
Overall lens fit acceptance on a scale of 0-4, 0.5 steps (Scale: 0=should not be worn, 4=perfect)
Time frame: Baseline (After 10 minutes of lens dispense)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stenfilcon A Test Lens | Overall Lens Fit Acceptance | 3.90 units on a scale | Standard Deviation 0.26 |
| Stenfilcon A Control Lens | Overall Lens Fit Acceptance | 3.81 units on a scale | Standard Deviation 0.34 |
Primary
Overall Lens Fit Acceptance
Overall lens fit acceptance on a scale of 0-4, 0.5 steps (Scale: 0=should not be worn, 4=perfect)
Time frame: 1 week on each study lenses
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stenfilcon A Test Lens | Overall Lens Fit Acceptance | 3.79 units on a scale | Standard Deviation 0.47 |
| Stenfilcon A Control Lens | Overall Lens Fit Acceptance | 3.83 units on a scale | Standard Deviation 0.35 |
Secondary
Lens Centration
Lens centration was assessed on a 3 point scale (1-Optimum, 2- Decentration acceptable, 3-Decentration unacceptable)
Time frame: Baseline - After 10 minutes of lens dispense
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Stenfilcon A Test Lens | Lens Centration | Optimum | 76 Participants |
| Stenfilcon A Test Lens | Lens Centration | Acceptable | 1 Participants |
| Stenfilcon A Test Lens | Lens Centration | Unacceptable | 0 Participants |
| Stenfilcon A Control Lens | Lens Centration | Optimum | 76 Participants |
| Stenfilcon A Control Lens | Lens Centration | Acceptable | 1 Participants |
| Stenfilcon A Control Lens | Lens Centration | Unacceptable | 0 Participants |
Secondary
Lens Centration
Lens centration was assessed on a 3 point scale (1-Optimum, 2- Decentration acceptable, 3-Decentration unacceptable)
Time frame: 1 week on each study lenses
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Stenfilcon A Test Lens | Lens Centration | Optimum | 75 Participants |
| Stenfilcon A Test Lens | Lens Centration | Acceptable | 2 Participants |
| Stenfilcon A Test Lens | Lens Centration | Unacceptable | 0 Participants |
| Stenfilcon A Control Lens | Lens Centration | Optimum | 76 Participants |
| Stenfilcon A Control Lens | Lens Centration | Acceptable | 1 Participants |
| Stenfilcon A Control Lens | Lens Centration | Unacceptable | 0 Participants |
Secondary
Post-blink Movement
Post-blink movement assessed on a scale of 0-4, 1 step size (Scale: 0=Insufficient, 1=Minimal, 2=Optimal, 3=Moderate, 4=Excessive)
Time frame: Baseline (after 10 minutes of lens dispense)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stenfilcon A Test Lens | Post-blink Movement | 2.04 units on a scale | Standard Deviation 0.34 |
| Stenfilcon A Control Lens | Post-blink Movement | 1.97 units on a scale | Standard Deviation 0.36 |
Secondary
Post-blink Movement
Post-blink movement assessed on a scale of 0-4, 1 step size (Scale: 0=Insufficient, 1=Minimal, 2=Optimal, 3=Moderate, 4=Excessive)
Time frame: 1 week on each study lenses
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stenfilcon A Test Lens | Post-blink Movement | 1.92 units on a scale | Standard Deviation 0.42 |
| Stenfilcon A Control Lens | Post-blink Movement | 1.96 units on a scale | Standard Deviation 0.34 |