Myopia, Refractive Ametropia
Conditions
Keywords
eye strain, eye fatigue
Brief summary
The purpose of this study was to compare the clinical performance of the new DAILIES® AquaComfort PLUS® FreshTech (DACP FreshTech) contact lenses to an already marketed daily disposable contact lens, DAILIES® AquaComfort PLUS® (DACP).
Detailed description
Subjects attended 4 scheduled visits for an expected duration of participation of 3 weeks.
Interventions
DEVICEDACP FreshTech contact lenses
Nelfilcon A soft contact lenses with a modified lens design
DEVICEDACP contact lenses
Nelfilcon A 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 35 Years
Healthy volunteers
No
Inclusion criteria
* At least 3 months of soft contact lens wearing experience; * Wears habitual lenses at least 5 days per week and at least 8 hours per day; * Uses digital devices (computer, tablet, and/or smart phone) for an average of 4 hours per day; * Experiences eye fatigue at least once per week attributable to digital device use with habitual lenses; * Is willing to NOT use rewetting/lubricating drops during the period of study product exposure; * Other protocol-specified inclusion criteria may apply.
Exclusion criteria
* Routinely sleeps in contact lenses; * Known pregnancy at time of enrollment; * Binocular vision issues or issues of eye alignment; * Any eye infection, inflammation, disease or abnormality that contraindicates contact lens wear; * Use of medications as specified in the protocol; * Ocular surgery within the past 12 months; * Other protocol-specified
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Distance Visual Acuity (VA) With Study Lenses | Week 1, each product | VA was assessed at a distance of 4 meters using a letter chart and was measured in logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with a lower logMAR value indicating better visual acuity. |
Countries
United States
Participant flow
Recruitment details
The study was conducted at a single investigative site in the United States.
Pre-assignment details
Of the 79 enrolled subjects, 11 were screen failures and 1 withdrew prior to randomization. This reporting group includes all randomized subjects (67).
Participants by arm
| Arm | Count |
|---|---|
| Overall DACP FreshTech contact lenses and DACP contact lenses worn during Period 1 and Period 2 in a crossover assignment, as randomized. | 67 |
| Total | 67 |
Baseline characteristics
| Characteristic | Overall |
|---|---|
| Age, Continuous | 22.4 years STANDARD_DEVIATION 3.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 62 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 8 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) White | 54 Participants |
| Sex: Female, Male Female | 57 Participants |
| Sex: Female, Male Male | 10 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 / 134 | 0 / 67 | 0 / 132 | 0 / 66 |
| other Total, other adverse events | 0 / 134 | 0 / 67 | 0 / 132 | 0 / 66 |
| serious Total, serious adverse events | 0 / 134 | 0 / 67 | 0 / 132 | 0 / 66 |
Outcome results
Primary
Mean Distance Visual Acuity (VA) With Study Lenses
VA was assessed at a distance of 4 meters using a letter chart and was measured in logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with a lower logMAR value indicating better visual acuity.
Time frame: Week 1, each product
Population: Full Analysis Set: All randomized subjects (as randomized) who were exposed to any study lenses, not including the optimized habitual and trial fit lenses.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DACP FreshTech | Mean Distance Visual Acuity (VA) With Study Lenses | -0.20 logMAR | Standard Deviation 0.06 |
| DACP | Mean Distance Visual Acuity (VA) With Study Lenses | -0.22 logMAR | Standard Deviation 0.05 |
Mixed Effects Repeated Measures Model