Myopia
Conditions
Keywords
Symptomatic
Brief summary
The purpose of this study is to evaluate the performance of DAILIES TOTAL1® and ACUVUE OASYS® 1-DAY and with respect to visual acuity in a symptomatic study population of monthly or bi-weekly replacement lens wearers.
Interventions
Water Gradient silicon hydrogel daily disposable contact lenses
Silicon hydrogel daily disposable contact lenses with HydraLuxe™ Technology
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Able to understand and must sign an IRB-approved informed consent form; * Soft contact lens wearers in both eyes during the past 3 months; * Best-corrected visual acuity (BCVA) 20/25 or better in each eye; * Willing to wear study lenses at least 3 days per week and at least 8 hours per day; * Willing to stop wearing habitual contact lenses for the duration of study participation.
Exclusion criteria
* Infection, inflammation, abnormality, condition, disease, surgery, or use of medications, as specified in the protocol; * Intolerance, hypersensitivity, or allergy to any component of the study products; * 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; * Monocular (only one eye with functional vision).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Monocular Corrected Distance Visual Acuity (VA) | Week 4 | Monocular (each eye) corrected (with spectacles or other visual corrective devices) VA was performed under dimmed room illumination using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart at distance. VA was reported in logMAR (logarithm of the minimum angle of resolution), with a lower logMAR indicating better visual acuity. No inferential hypotheses was planned for this endpoint. |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited from 4 investigational sites located in the United States.
Pre-assignment details
Of the 39 enrolled, 2 subjects were discontinued (1 screen failure, 1 due to lens power not available) prior to randomization. This reporting group includes all randomized subjects (37).
Participants by arm
| Arm | Count |
|---|---|
| TOTAL1 Delefilcon A contact lenses worn bilaterally for 4 weeks in a daily disposable modality | 18 |
| 1-DAY Senofilcon A contact lenses worn bilaterally for 4 weeks in a daily disposable modality | 19 |
| Total | 37 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
Baseline characteristics
| Characteristic | TOTAL1 | 1-DAY | Total |
|---|---|---|---|
| Age, Continuous | 36.2 years STANDARD_DEVIATION 8.4 | 36.9 years STANDARD_DEVIATION 9.2 | 36.6 years STANDARD_DEVIATION 8.7 |
| 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 | 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 | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized White | 18 Participants | 18 Participants | 36 Participants |
| Sex: Female, Male Female | 12 Participants | 16 Participants | 28 Participants |
| Sex: Female, Male Male | 6 Participants | 3 Participants | 9 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 | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 18 | 0 / 18 | 0 / 19 | 0 / 19 | 0 / 19 |
| other Total, other adverse events | 0 / 18 | 0 / 18 | 0 / 18 | 1 / 19 | 1 / 19 | 1 / 19 |
| serious Total, serious adverse events | 0 / 18 | 0 / 18 | 0 / 18 | 0 / 19 | 0 / 19 | 0 / 19 |
Outcome results
Primary
Monocular Corrected Distance Visual Acuity (VA)
Monocular (each eye) corrected (with spectacles or other visual corrective devices) VA was performed under dimmed room illumination using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart at distance. VA was reported in logMAR (logarithm of the minimum angle of resolution), with a lower logMAR indicating better visual acuity. No inferential hypotheses was planned for this endpoint.
Time frame: Week 4
Population: Safety Analysis Set with non-missing response
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TOTAL1 | Monocular Corrected Distance Visual Acuity (VA) | -0.01 logMAR | Standard Deviation 0.04 |
| 1-DAY | Monocular Corrected Distance Visual Acuity (VA) | -0.02 logMAR | Standard Deviation 0.05 |