Refractive Errors
Conditions
Keywords
Contact Lenses
Brief summary
The purpose of this study is to assess the clinical performance of DAILIES TOTAL1® spherical soft contact lenses over approximately 1 week of daily wear.
Detailed description
Subjects will be expected to attend 2 visits (Visit 1 Screen/Baseline/ Dispense; and Visit 2 Week 1 Follow-up/ Exit). The total duration of a subject's participation in the study as well as exposure to the contact lenses will be approximately 1 week (6-8 days of contact lens wear).
Interventions
Daily disposable, silicone hydrogel spherical contact lenses
Sponsors
Alcon Research
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
In this single arm study, the subject will be masked to the lens type.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Key Inclusion Criteria: * Current wearer of commercial spherical soft contact lenses in both eyes with at least 3 months of wearing experience, with a minimum wearing time of 5 days per week and 10 hours per day; * Manifest cylinder less than or equal to 0.75 diopter (D) in each eye; * Best corrected distance visual acuity better than or equal to 20/25 (Snellen) in each eye. Key
Exclusion criteria
* Current or prior habitual DAILIES TOTAL1 soft contact lens wear in the past 3 months prior to consent; * Monovision contact lens wear; * Wearing habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Distance VA With Study Lenses at Week 1 | Week 1 | Visual acuity (VA) was measured for each eye individually with study lenses on eye using letter charts. VA was recorded in Snellen where 20/20 represents normal distance eyesight and 20/15 represents better than normal eyesight. No hypothesis testing was prespecified for this endpoint. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from 6 investigative sites located in 1 country (US).
Pre-assignment details
Of the 97 enrolled, 1 subject was exited as a screen failure prior to being exposed to the product. This reporting group includes all participants who were exposed to the product (96).
Participants by arm
| Arm | Count |
|---|---|
| DAILIES TOTAL1 Delefilcon A contact lenses (daily disposable, silicone hydrogel spherical contact lenses) worn in both eyes for the typical number of hours the subject wears his/her habitual contact lenses. The lenses were worn in a daily disposable manner. | 96 |
| Total | 96 |
Baseline characteristics
| Characteristic | DAILIES TOTAL1 |
|---|---|
| Age, Continuous | 35.9 years STANDARD_DEVIATION 8.7 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants |
| Race/Ethnicity, Customized Black or African American | 9 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 3 Participants |
| Race/Ethnicity, Customized Multi-racial | 1 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 93 Participants |
| Race/Ethnicity, Customized Other | 2 Participants |
| Race/Ethnicity, Customized White | 83 Participants |
| Sex: Female, Male Female | 65 Participants |
| Sex: Female, Male Male | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 96 | 0 / 192 | 0 / 96 |
| other Total, other adverse events | 0 / 96 | 0 / 192 | 0 / 96 |
| serious Total, serious adverse events | 0 / 96 | 0 / 192 | 0 / 96 |
Outcome results
Primary
Distance VA With Study Lenses at Week 1
Visual acuity (VA) was measured for each eye individually with study lenses on eye using letter charts. VA was recorded in Snellen where 20/20 represents normal distance eyesight and 20/15 represents better than normal eyesight. No hypothesis testing was prespecified for this endpoint.
Time frame: Week 1
Population: The safety analysis set included all subjects/eyes exposed to DAILIES TOTAL1 lenses evaluated in this study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DAILIES TOTAL1 | Distance VA With Study Lenses at Week 1 | 20/15 | 95 eyes |
| DAILIES TOTAL1 | Distance VA With Study Lenses at Week 1 | 20/20 | 92 eyes |
| DAILIES TOTAL1 | Distance VA With Study Lenses at Week 1 | 20/25 | 5 eyes |