Refractive Error, Myopia
Conditions
Keywords
Visual acuity, VA, Daily disposable contact lenses
Brief summary
The purpose of this study was to evaluate visual acuity at distance when wearing DDT2 contact lenses compared to Acuvue Moist contact lenses.
Detailed description
Subjects were expected to attend 3 study visits and wear study lenses for approximately 14 - 20 days (7 - 10 days for each product).
Interventions
Investigational daily disposable soft contact lenses
Commercially available daily disposable soft contact lenses
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: * Able to understand and sign an Informed Consent Form that has been approved by an Institutional Review Board. * Willing and able to attend all scheduled study visits as required per protocol. * Current wearer of spherical soft contact lenses. Key
Exclusion criteria
* Any ocular condition that contraindicates contact lens wear. * Previous or current habitual wearer of ACUVUE® MOIST or DAILIES TOTAL1® contact lenses.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Least Squares Mean Distance Visual Acuity With Study Lenses | Day 8, each product | Visual acuity was assessed and 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 performed at 5 study centers in the United States (US).
Pre-assignment details
This reporting group includes all randomized subjects (92).
Participants by arm
| Arm | Count |
|---|---|
| DDT2, Then 1DAVM Verofilcon A contact lenses worn first, with etafilcon A contact lenses worn second, as randomized. Each product worn bilaterally (in both eyes) for 8 -1/+2 days in a daily disposable modality. | 46 |
| 1DAVM, Then DDT2 Etafilcon A contact lenses worn first, with verofilcon A contact lenses worn second, as randomized. Each product worn bilaterally (in both eyes) for 8 -1/+2 days in a daily disposable modality. | 46 |
| Total | 92 |
Baseline characteristics
| Characteristic | Total | DDT2, Then 1DAVM | 1DAVM, Then DDT2 |
|---|---|---|---|
| Age, Continuous | 32.6 years STANDARD_DEVIATION 8.2 | 33.6 years STANDARD_DEVIATION 8.5 | 31.5 years STANDARD_DEVIATION 7.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 10 Participants | 2 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 82 Participants | 44 Participants | 38 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 | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Black or African American | 6 Participants | 2 Participants | 4 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Other | 2 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 83 Participants | 43 Participants | 40 Participants |
| Region of Enrollment United States | 92 participants | 46 participants | 46 participants |
| Sex: Female, Male Female | 59 Participants | 31 Participants | 28 Participants |
| Sex: Female, Male Male | 33 Participants | 15 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 184 | 0 / 92 | 0 / 184 | 0 / 92 |
| other Total, other adverse events | 0 / 184 | 0 / 92 | 0 / 184 | 0 / 92 |
| serious Total, serious adverse events | 0 / 184 | 0 / 92 | 0 / 184 | 0 / 92 |
Outcome results
Primary
Least Squares Mean Distance Visual Acuity With Study Lenses
Visual acuity was assessed and 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, each product
Population: Full Analysis Set (FAS): All randomized subjects who were exposed to any study lenses evaluated in this study, with the exception of the lenses used at Visit 1 for optimization and fitting.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| DDT2 | Least Squares Mean Distance Visual Acuity With Study Lenses | -0.13 logMar | Standard Error 0.008 |
| 1DAVM | Least Squares Mean Distance Visual Acuity With Study Lenses | -0.12 logMar | Standard Error 0.008 |
Mixed effects repeated measures model