Refractive Errors
Conditions
Brief summary
The purpose of this study is to evaluate the visual performance of DAILIES® AquaComfort Plus® (DACP) Digital lenses by assessing distance visual acuity (VA) as compared to DACP sphere contact lenses after one week of wear.
Interventions
DEVICENelfilcon A digital contact lenses
Silicone hydrogel digital contact lenses
Silicone hydrogel spherical 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 35 Years
Healthy volunteers
No
Inclusion criteria
* Willing and able to sign an IRB/IEC approved Informed Consent form; * Current wearer of DACP spherical contact lenses (at least 2 months in current correction), with a minimum wearing time of 5 days per week and 8 hours per day; * Experiencing symptoms of eye strain from using technology; * Willing to wear study lenses each day; * Possess spectacles that provide a corrected visual acuity of 20/40 or better in both eyes (OU) and be willing to wear them (as needed); * Willing to NOT use rewetting/lubricating drops at any time during the study; * Currently using digital devices (computer, tablet, and/or smart phone) for a minimum of 5 days per week and 4 hours per day; * Willing to NOT use any near aid (e.g. reading glasses) at any time during the study.
Exclusion criteria
* Conditions, use of medications, injury, or surgery, as specified in the protocol; * 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); * Pregnant.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Distance Visual Acuity (VA) (logMAR, OU) | Day 7, each product | VA was tested under photopic (well-lit) conditions using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart positioned 6 meters from the subject. VA was collected bilaterally (OU) and measured in logMAR (logarithm of the minimum angle of resolution), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower numeric value represents better visual acuity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Vision | Day 7, each product | Subjective rating of overall vision on a scale of 1 (Poor) to 10 (Excellent). Both eyes contributed to the analysis. |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited from 5 investigative sites located in the United States.
Pre-assignment details
All 60 enrolled subjects were randomized and exposed to the investigational products.
Participants by arm
| Arm | Count |
|---|---|
| Overall Nelfilcon A digital contact lenses and nelfilcon A contact lenses worn during Period 1 and Period 2 in a crossover assignment, as randomized. | 60 |
| Total | 60 |
Baseline characteristics
| Characteristic | Overall |
|---|---|
| Age, Continuous | 25.2 years STANDARD_DEVIATION 5.3 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants |
| Race/Ethnicity, Customized Black or African American | 3 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race/Ethnicity, Customized Other | 1 Participants |
| Race/Ethnicity, Customized White | 56 Participants |
| Sex: Female, Male Female | 36 Participants |
| Sex: Female, Male Male | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 60 | 0 / 60 |
| other Total, other adverse events | 0 / 60 | 0 / 60 |
| serious Total, serious adverse events | 0 / 60 | 0 / 60 |
Outcome results
Primary
Distance Visual Acuity (VA) (logMAR, OU)
VA was tested under photopic (well-lit) conditions using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart positioned 6 meters from the subject. VA was collected bilaterally (OU) and measured in logMAR (logarithm of the minimum angle of resolution), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower numeric value represents better visual acuity.
Time frame: Day 7, each product
Population: Full Analysis Set with non-missing response
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DACP Digital | Distance Visual Acuity (VA) (logMAR, OU) | -0.11 logMAR | Standard Deviation 0.1 |
| DACP | Distance Visual Acuity (VA) (logMAR, OU) | -0.12 logMAR | Standard Deviation 0.09 |
Secondary
Overall Vision
Subjective rating of overall vision on a scale of 1 (Poor) to 10 (Excellent). Both eyes contributed to the analysis.
Time frame: Day 7, each product
Population: Full Analysis Set with non-missing response
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DACP Digital | Overall Vision | 8.8 units on a scale | Standard Deviation 1 |
| DACP | Overall Vision | 8.9 units on a scale | Standard Deviation 1 |