Refractive Error
Conditions
Brief summary
The purpose of this study is to compare DAILIES TOTAL1® (DT1) to 1-DAY ACUVUE® TruEye® (TE) for Investigator-rated successful lens centration in Japanese population.
Interventions
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Must sign an informed consent form; * Habitual current daily disposable soft contact lenses wearer; * Symptoms of contact lens discomfort as defined by the Symptomatology (Eligibility) Questionnaire; * Lenses within the power range specified in the protocol; * Vision correctable to 20/25 or 0.1 logMAR (logarithmic minimum angle of resolution) or better in each eye at distance with pre-study contact lenses at Visit1; * Acceptable lens fit with both study contact lenses; * Willing to wear lenses every day or at least for a minimum of 10 days, 6 hours per day, every day if possible and attend all study visits; * Other protocol-specified inclusion criteria may apply.
Exclusion criteria
* Currently wearing DT1 or TE sphere lenses; * Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear; * Use of systemic or ocular medications in which contact lens wear could be contraindicated as determined by the investigator; * Eye injury or surgery within 12 weeks immediately prior to enrollment; * History of herpetic keratitis, ocular surgery or irregular cornea; * Prior refractive surgery; * Monocular (only 1 eye with functional vision) or fit with only 1 lens; * Participation in any clinical trial within 30 days of the enrollment visit; * Other protocol-specified
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects With Investigator-rated Lens Centration of Optimal After 10 Days of Wear | Day 10, each product | Lens centration was assessed by the investigator on a 5-point scale, where 0=Optimal and 4=Severe decentration (with corneal exposure). Both eyes contributed to the analysis. |
Countries
Japan
Participant flow
Recruitment details
Subjects were recruited from 6 study sites located in Japan.
Pre-assignment details
Of the 104 subjects, 5 were exited as screen failures prior to being enrolled. This reporting group includes all enrolled subjects (99).
Participants by arm
| Arm | Count |
|---|---|
| Overall Delefilcon A and narafilcon A contact lenses worn during Period 1 and Period 2 in a crossover assignment. | 99 |
| Total | 99 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Period 1, First 10 Days of Wear | Adverse Event | 0 | 1 |
| Period 1, First 10 Days of Wear | Withdrawal by Subject | 1 | 2 |
Baseline characteristics
| Characteristic | Overall |
|---|---|
| Age, Continuous | 39.9 years STANDARD_DEVIATION 9.7 |
| Sex: Female, Male Female | 72 Participants |
| Sex: Female, Male Male | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 104 | 7 / 96 | 23 / 98 |
| serious Total, serious adverse events | 0 / 104 | 0 / 96 | 0 / 98 |
Outcome results
Primary
Percentage of Subjects With Investigator-rated Lens Centration of Optimal After 10 Days of Wear
Lens centration was assessed by the investigator on a 5-point scale, where 0=Optimal and 4=Severe decentration (with corneal exposure). Both eyes contributed to the analysis.
Time frame: Day 10, each product
Population: This analysis population includes all subjects who used the study device and in whom data after the use of the study device were available (Full Analysis Set).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dailies Total1 | Percentage of Subjects With Investigator-rated Lens Centration of Optimal After 10 Days of Wear | 89.5 percentage of subjects |
| TruEye | Percentage of Subjects With Investigator-rated Lens Centration of Optimal After 10 Days of Wear | 47.4 percentage of subjects |