Refractive Errors, Ametropia, Myopia
Conditions
Keywords
Contact lenses
Brief summary
The purpose of this study is to compare the clinical performance of DAILIES TOTAL1 ( DT1) contact lenses with Infuse contact lenses.
Detailed description
Subjects will wear two products and be expected to attend 3 office visits. The individual duration of participation will be approximately 3 weeks, which includes 16 to 22 days of lens wear.
Interventions
Commercially available silicone hydrogel contact lenses used as indicated
Commercially available silicone hydrogel contact lenses used as indicated
Sponsors
Alcon Research
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
Key Inclusion Criteria: * Habitually wears soft contact lenses in both eyes at least 5 days per week and at least 10 hours per day; * At least 3 months of contact lens wearing experience; * Less than or equal to 0.75 diopter (D) astigmatism in each eye; * Best Corrected Visual Acuity (BCVA) better than or equal to 20/25 in each eye. * Other protocol-defined inclusion criteria may apply. Key
Exclusion criteria
* Current/previous DAILIES TOTAL1 and/or Infuse habitual lens wearer; * Monovision and/or multifocal lens wearer; * Routinely sleeps in habitual contact lenses. * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Least Squares Mean Distance VA (logMAR) With Study Lenses | Day 8 (-0/+3), each study lens type | Distance visual acuity (VA) was assessed with study lenses in place. VA was collected for each eye separately using logarithmic of the Minimum Angle of Resolution (logMAR) charts. A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity (normal visual acuity), with a negative value denoting better than 20/20 visual acuity. |
Countries
United States
Participant flow
Recruitment details
This study was conducted at 8 investigative sites in the United States.
Pre-assignment details
Of the 112 enrolled, one subject was exited prior to randomization as a screen failure. This reporting group includes all randomized subjects (111).
Participants by arm
| Arm | Count |
|---|---|
| DT1, Then Infuse Delefilcon A contact lenses worn first, with kalifilcon A contact lenses worn second, as randomized. Each study lens type was worn bilaterally (in both eyes) for 8 (-0/+3) days on a daily wear, daily disposable basis. | 55 |
| Infuse, Then DT1 Kalifilcon A contact lenses worn first, with delefilcon A contact lenses worn second, as randomized. Each study lens type was worn bilaterally (in both eyes) for 8 (-0/+3) days on a daily wear, daily disposable basis. | 56 |
| Total | 111 |
Baseline characteristics
| Characteristic | Infuse, Then DT1 | Total | DT1, Then Infuse |
|---|---|---|---|
| Age, Continuous | 32.4 years STANDARD_DEVIATION 7.4 | 33.0 years STANDARD_DEVIATION 7.8 | 33.7 years STANDARD_DEVIATION 8.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 9 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 53 Participants | 102 Participants | 49 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Black or African American | 3 Participants | 7 Participants | 4 Participants |
| Race/Ethnicity, Customized Multi-racial | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized White | 52 Participants | 102 Participants | 50 Participants |
| Region of Enrollment United States | 56 participants | 111 participants | 55 participants |
| Sex: Female, Male Female | 36 Participants | 77 Participants | 41 Participants |
| Sex: Female, Male Male | 20 Participants | 34 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 111 | 0 / 222 | 0 / 111 | 0 / 222 | 0 / 111 |
| other Total, other adverse events | 0 / 111 | 0 / 222 | 0 / 111 | 0 / 222 | 0 / 111 |
| serious Total, serious adverse events | 0 / 111 | 0 / 222 | 0 / 111 | 0 / 222 | 0 / 111 |
Outcome results
Primary
Least Squares Mean Distance VA (logMAR) With Study Lenses
Distance visual acuity (VA) was assessed with study lenses in place. VA was collected for each eye separately using logarithmic of the Minimum Angle of Resolution (logMAR) charts. A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity (normal visual acuity), with a negative value denoting better than 20/20 visual acuity.
Time frame: Day 8 (-0/+3), each study lens type
Population: FAS with non-missing response (eye)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| DT1 (Delefilcon A) | Least Squares Mean Distance VA (logMAR) With Study Lenses | -0.10 logMAR | Standard Error 0.006 |
| Infuse (Kalifilcon A) | Least Squares Mean Distance VA (logMAR) With Study Lenses | -0.10 logMAR | Standard Error 0.006 |