Refractive Error
Conditions
Brief summary
The purpose of this study is to compare the lens fit characteristics, specifically lens centration, of ACUVUE® OASYS® 1-DAY (AO1D) contact lenses and DAILIES TOTAL1® (DT1) contact lenses.
Interventions
Sponsors
Alcon, a Novartis Company
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
No
Inclusion criteria
* Must sign informed consent form; * Adapted, current daily disposable soft contact lens wearer who typically wears lenses every day, or at least 5 days per week, 6 hours per day; * Symptoms of contact lens discomfort as defined by the Symptomatology (Eligibility) Pre-screening questionnaire; * Prescription within -1.00 Diopter (D) to -6.00D to be fitted with study contact lenses; * Cylinder equal or lower than -0.75D in both eyes; * Vision correctable to 20/25 or 0.1 logMAR (Logarithmic minimum angle of resolution) or better in each eye at distance with both study lenses at Visit 1; * Can be successfully fitted with both study lenses at Visit 1; * Willing to wear lenses every day or at least 5 days per week, 6 hours per day and attend all study visits; * Other protocol-specified inclusion criteria may apply.
Exclusion criteria
* Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear; * Use of systemic or ocular medications for which contact lens wear could be contraindicated as determined by the Investigator; * Monocular (only 1 eye with functional vision) or fit with only 1 lens; * Fitted with monovision; * Prior refractive surgery; * History of herpetic keratitis, ocular surgery, or irregular cornea; * Pregnant or lactating; * Use of mechanical eyelid therapy or eyelid scrubs within 14 days before Visit 1 and not willing to discontinue during the study; * Participation in any clinical study within 30 days of Visit 1; * Current DT1 or AO1D lens wearer; * Other protocol-specified
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Lenses Graded as 0 or 1 for Lens Centration at Day 14 | Day 14, each product | Lens centration, was assessed by the investigator for each eye individually and rated on a 5-point scale: 0=centered/optimal, 1=slight decentration, 2=mild decentration, 3=moderate decentration, 4=severe decentration. The combined percentage of lenses assessed as centered or slight decentration is reported. Lenses from both eyes contributed to the percentage. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ex Vivo Critical Coefficient of Friction (CCOF) at Day 14 | Day 14, each product | The ex vivo CCOF (ratio of the force of friction between two bodies and the force pressing them together) was measured by the incline plane technique after 16 hours of lens wear. Worn lenses were collected and analyzed for a subset of subjects (all subjects from one site only) who attended the Day 14 visit (Visit 2 and Visit 3) after 16 hours of lens wear. Only lens worn on the right eye (OD) was measured in each subject per each lens brand. CCOF values for contact lenses range from near zero to approximately 0.10 using the inclined plane method. A lower CCOF indicates higher contact lens lubricity. |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited from 12 study centers located in the United States.
Pre-assignment details
Of the 252 enrolled, 5 subjects were exited prior to randomization and 1 randomized subject was exited prior to treatment. This reporting group includes all randomized subjects who were exposed to a study product (test or control) (246).
Participants by arm
| Arm | Count |
|---|---|
| Overall Delefilcon A and senofilcon A contact lenses worn during Period 1 and Period 2 in a crossover assignment. | 246 |
| Total | 246 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Period 1, First 14 Days of Wear | Reason not given | 0 | 1 |
| Period 1, First 14 Days of Wear | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Overall |
|---|---|
| Age, Continuous | 30.7 years STANDARD_DEVIATION 8.44 |
| Sex: Female, Male Female | 183 Participants |
| Sex: Female, Male Male | 63 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 252 | 0 / 246 | 0 / 246 |
| other Total, other adverse events | 0 / 252 | 0 / 246 | 0 / 246 |
| serious Total, serious adverse events | 0 / 252 | 0 / 246 | 0 / 246 |
Outcome results
Primary
Percentage of Lenses Graded as 0 or 1 for Lens Centration at Day 14
Lens centration, was assessed by the investigator for each eye individually and rated on a 5-point scale: 0=centered/optimal, 1=slight decentration, 2=mild decentration, 3=moderate decentration, 4=severe decentration. The combined percentage of lenses assessed as centered or slight decentration is reported. Lenses from both eyes contributed to the percentage.
Time frame: Day 14, each product
Population: Full Analysis Set. Number Analyzed is the number of eyes with non-missing response.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DAILIES TOTAL1 | Percentage of Lenses Graded as 0 or 1 for Lens Centration at Day 14 | 100.0 percentage of lenses |
| AO1D | Percentage of Lenses Graded as 0 or 1 for Lens Centration at Day 14 | 99.4 percentage of lenses |
Secondary
Ex Vivo Critical Coefficient of Friction (CCOF) at Day 14
The ex vivo CCOF (ratio of the force of friction between two bodies and the force pressing them together) was measured by the incline plane technique after 16 hours of lens wear. Worn lenses were collected and analyzed for a subset of subjects (all subjects from one site only) who attended the Day 14 visit (Visit 2 and Visit 3) after 16 hours of lens wear. Only lens worn on the right eye (OD) was measured in each subject per each lens brand. CCOF values for contact lenses range from near zero to approximately 0.10 using the inclined plane method. A lower CCOF indicates higher contact lens lubricity.
Time frame: Day 14, each product
Population: Full Analysis Set. Number Analyzed is the number of eyes with non-missing responses, including only subjects from one site.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DAILIES TOTAL1 | Ex Vivo Critical Coefficient of Friction (CCOF) at Day 14 | 0.0468 unitless | Standard Deviation 0.00557 |
| AO1D | Ex Vivo Critical Coefficient of Friction (CCOF) at Day 14 | 0.0675 unitless | Standard Deviation 0.00599 |