Refractive Error
Conditions
Brief summary
The purpose of this study is to evaluate the incidence of ocular discomfort device-related adverse events with DAILIES TOTAL1® with UV Absorber (DT1 UV) contact lenses compared with current DAILIES TOTAL1® (DT1) contact lenses.
Interventions
DEVICEDelefilcon A contact lenses with UV Absorber
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Must sign an Informed Consent document; * Current wearers of commercial DT1 lenses (for at least 3 months), with a minimum wearing time of 5 days per week and 8 hours per day; * Spherical contact lens correction within the range of -2.00 to -4.00 Diopter (D) in both eyes; * Manifest astigmatism less than or equal to 0.75 D (at screening); * Best-corrected visual acuity (BCVA) greater than or equal to 20/25 in each eye (as determined by manifest refraction at screening); * Other protocol-specified inclusion criteria may apply.
Exclusion criteria
* Eye injury in either eye within 12 weeks prior to study enrollment; * Any anterior segment infection, inflammation, disease, or abnormality that contraindicates contact lens wear as determined by the Investigator; * Use of systemic or ocular medications for which contact lens wear could be contraindicated, including topical ocular medications and lubrication drops that would require instillation during contact lens wear; * History of herpetic keratitis; * History of refractive surgery or irregular cornea; * Pathologically dry eye that precludes contact lens wear; * Concurrent participation (or within the previous 30 days) in a contact lens or lens care product clinical trial; * Monocular (only 1 eye with functional vision); * Other protocol-specified
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence (Number) of Ocular Discomfort Device-related Adverse Events (AEs) | Day 1 at Hour 9 ± 3 hours | An AE was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. Reported in units of eyes. |
Participant flow
Recruitment details
Subjects were recruited from 5 investigational sites located in the United States.
Pre-assignment details
Of the 81 enrolled, 1 subject exited as a screen failure prior to randomization. This reporting group includes all randomized subjects (80).
Participants by arm
| Arm | Count |
|---|---|
| DT1 UV Delefilcon A contact lenses with Ultraviolet (UV) Absorber worn bilaterally (in both eyes) for 9 hours | 41 |
| Dailies Total1 (DT1) Delefilcon A contact lenses worn bilaterally for 9 hours | 39 |
| Total | 80 |
Baseline characteristics
| Characteristic | DT1 UV | Dailies Total1 (DT1) | Total |
|---|---|---|---|
| Age, Continuous | 36.2 years STANDARD_DEVIATION 8.5 | 35.3 years STANDARD_DEVIATION 9.9 | 35.8 years STANDARD_DEVIATION 9.2 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 3 Participants | 2 Participants | 5 Participants |
| Race/Ethnicity, Customized Black or African American | 2 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Multi-Racial | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Island | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized White | 36 Participants | 35 Participants | 71 Participants |
| Sex: Female, Male Female | 34 Participants | 23 Participants | 57 Participants |
| Sex: Female, Male Male | 7 Participants | 16 Participants | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 41 | 0 / 39 |
| other Total, other adverse events | 0 / 41 | 0 / 39 |
| serious Total, serious adverse events | 0 / 41 | 0 / 39 |
Outcome results
Primary
Incidence (Number) of Ocular Discomfort Device-related Adverse Events (AEs)
An AE was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. Reported in units of eyes.
Time frame: Day 1 at Hour 9 ± 3 hours
Population: Full Analysis Set
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| DT1 UV | Incidence (Number) of Ocular Discomfort Device-related Adverse Events (AEs) | 0 Eyes |
| Dailies Total1 (DT1) | Incidence (Number) of Ocular Discomfort Device-related Adverse Events (AEs) | 0 Eyes |