Myopia
Conditions
Keywords
DAILIES TOTAL1, contact lenses, myopia
Brief summary
The purpose of this crossover study was to evaluate the end-of-day comfort of two commercially available, daily disposable, silicone hydrogel contact lenses.
Interventions
CE-marked, silicone hydrogel, soft contact lenses for daily wear, daily disposable use, worn bilaterally for two weeks in either Period One or Period Two
CE-marked, silicone hydrogel, soft contact lenses for daily wear, daily disposable use, worn bilaterally for two weeks in either Period One or Period Two
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Sign written Informed Consent Document. * Currently wearing soft contact lenses in both eyes and identified as symptomatic based on questionnaire responses. * Currently wearing either daily disposable contact lenses or weekly/monthly replacement contact lenses. * Able to achieve visual acuity of at least 6/7.5 in each eye with study lenses in the available parameters. * Willing to wear study lenses for at least eight hours per day and at least five days per week. * Other protocol-defined inclusion criteria may apply.
Exclusion criteria
* Has not worn contact lenses before. * Currently wearing DAILIES TOTAL1 or 1-DAY ACUVUE TRUEYE contact lenses. * Any systemic or ocular disease or disorder that would negatively affect the conduct or outcome of the study. * Ocular surgery/trauma within the last six months. * Topical ocular or systemic use of antibiotics within seven days of enrollment. * Pregnant or nursing women. * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| End-of-day Comfort | Week 2 | End-of-day comfort was interpreted and reported by the participant on a questionnaire as a single, retrospective measurement of two weeks of wear. Participants were asked, Please rate the study lenses you have been wearing the in the following area: End-of-day comfort and recorded their response on a continuous 1-10 Likert scale (1=poor and 10=excellent). |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from two study centers in Finland, three study centers in German, and three study centers in the UK.
Pre-assignment details
Of the 123 participants enrolled, two were excluded prior to randomization. This reporting group includes all participants enrolled and exposed to Test Article (121).
Participants by arm
| Arm | Count |
|---|---|
| OVERALL Delefilcon A contact lenses and narafilcon A contact lenses worn in randomized order. Each product was worn bilaterally on a daily wear, daily disposable basis for two weeks. | 121 |
| Total | 121 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| First Two Weeks of Wear | Adverse Event | 0 | 1 |
| First Two Weeks of Wear | Time/job conflict | 0 | 1 |
| Second Two Weeks of Wear | Adverse Event | 0 | 1 |
Baseline characteristics
| Characteristic | OVERALL |
|---|---|
| Age, Continuous | 34.0 years STANDARD_DEVIATION 10.4 |
| Sex: Female, Male Female | 85 Participants |
| Sex: Female, Male Male | 36 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 119 | 0 / 121 |
| serious Total, serious adverse events | 0 / 119 | 0 / 121 |
Outcome results
Primary
End-of-day Comfort
End-of-day comfort was interpreted and reported by the participant on a questionnaire as a single, retrospective measurement of two weeks of wear. Participants were asked, Please rate the study lenses you have been wearing the in the following area: End-of-day comfort and recorded their response on a continuous 1-10 Likert scale (1=poor and 10=excellent).
Time frame: Week 2
Population: This reporting group includes all participants who finished the study, minus any major protocol deviations as determined by masked review.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DAILIES TOTAL1 | End-of-day Comfort | 8.3 Units on a scale | Standard Deviation 1.91 |
| TRUEYE | End-of-day Comfort | 6.6 Units on a scale | Standard Deviation 2.22 |