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 Clariti contact lenses.
Detailed description
Subjects were expected to attend 3 study visits and wear the DDT2 and Clariti study lenses in a crossover design 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 clariti® 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 8 study centers in the United States (US).
Pre-assignment details
Of the 154 enrolled, 2 were exited from the study as screen failures and 1 subject was randomized but not exposed. This reporting group includes all exposed subjects (151).
Participants by arm
| Arm | Count |
|---|---|
| DDT2, Then Clariti Verofilcon A contact lenses worn first, with somofilcon A contact lenses worn second, as randomized. Each product was worn bilaterally (in both eyes) for 8 -1/+2 days in a daily disposable modality.
Verofilcon A contact lenses: Investigational daily disposable soft contact lenses
Somofilcon A contact lenses: Commercially available daily disposable soft contact lenses | 76 |
| Clariti, Then DDT2 Somofilcon A contact lenses worn first, with verofilcon A contact lenses worn second, as randomized. Each product was worn bilaterally (in both eyes) for 8 -1/+2 days in a daily disposable modality.
Verofilcon A contact lenses: Investigational daily disposable soft contact lenses
Somofilcon A contact lenses: Commercially available daily disposable soft contact lenses | 75 |
| Total | 151 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Second Wear (8 -1/+2 Days) | Adverse Event | 0 | 1 |
| Second Wear (8 -1/+2 Days) | Other | 1 | 0 |
Baseline characteristics
| Characteristic | Clariti, Then DDT2 | Total | DDT2, Then Clariti |
|---|---|---|---|
| Age, Continuous | 31.8 years STANDARD_DEVIATION 7.9 | 33.5 years STANDARD_DEVIATION 8.1 | 35.1 years STANDARD_DEVIATION 7.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 9 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 69 Participants | 142 Participants | 73 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 | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Black or African American | 1 Participants | 6 Participants | 5 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 | 2 Participants | 3 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 67 Participants | 132 Participants | 65 Participants |
| Region of Enrollment United States | 75 participants | 151 participants | 76 participants |
| Sex: Female, Male Female | 47 Participants | 103 Participants | 56 Participants |
| Sex: Female, Male Male | 28 Participants | 48 Participants | 20 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 / 302 | 0 / 151 | 0 / 298 | 0 / 149 |
| other Total, other adverse events | 0 / 302 | 0 / 151 | 0 / 298 | 0 / 149 |
| serious Total, serious adverse events | 0 / 302 | 0 / 151 | 0 / 298 | 0 / 149 |
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/eyes with non-missing responses, 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 | -0.08 logMAR | Standard Error 0.006 |
| Clariti | Least Squares Mean Distance Visual Acuity With Study Lenses | -0.08 logMAR | Standard Error 0.006 |
Mixed effects repeated measures model