Myopia
Conditions
Keywords
contact lenses, myopia
Brief summary
The purpose of this study was to compare the subjective performance of DAILIES TOTAL1® daily disposable contact lenses to that of 1-DAY ACUVUE® TruEye® daily disposable contact lenses.
Interventions
DEVICEDelefilcon A contact lenses (DAILIES TOTAL1®)
Commercially marketed silicone hydrogel, single-vision contact lenses for daily wear, daily disposable use
DEVICENarafilcon B contact lenses (1-DAY ACUVUE® TruEye®)
Commercially marketed, silicone hydrogel single-vision contact lenses for daily wear, daily disposable use
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Sign written Informed Consent Document and HIPAA form. * Be current weekly/monthly replacement contact lens wearer. * Be willing to not sleep in contact lenses during the study period. * Require vision correction in both eyes, with a contact lens prescription in protocol-specified power range. * Have best corrected visual acuity of at least 20/25 in each eye. * Be willing to wear study lenses for at least 8 hours/day and at least 5 days/week. * Use re-wetting drops less than once per day and be willing to discontinue use of rewetting drops while wearing the study contact lenses. * Other protocol-specified inclusion criteria may apply.
Exclusion criteria
* Be a neophyte or current wearer of daily disposable lenses. * Require monovision correction or use multifocal contact lenses. * Have any systemic or ocular disease or disorder, complicating factor, or structural abnormality that would negatively affect the conduct or outcome of the study. * Have a history of ocular surgery/trauma within the last 6 months. * Use topical ocular or systemic antibiotics within 7 days of enrollment. * Use topical ocular or systemic corticosteroids within 14 days of enrollment, continuing throughout the study. * Have participated in any other ophthalmic drug or device clinical trial within 30 days of enrollment. * Have habitually worn contact lenses on an extended wear basis (sleeping in habitual contact lenses for at least 2 nights per week) in the last 3 months prior to enrollment. * Use re-wetting drops once or more per day. * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Comfort | Day 8 | Overall comfort was interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 8 days of wear. Overall comfort was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent. Both eyes contributed to the mean. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Quality of Vision | Day 8 | Overall quality of vision was interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 8 days of wear. Overall quality of vision was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent. Both eyes contributed to the mean. |
| End of Day Comfort | Day 8 | End of day comfort was interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 8 days of wear. End of day comfort was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent. Both eyes contributed to the mean. |
Participant flow
Recruitment details
Participants were recruited from 18 study centers located in the US.
Pre-assignment details
Of the 330 participants enrolled, 17 were exited from the study prior to randomization and dispense of product.This reporting group includes all randomized and dispensed participants (313).
Participants by arm
| Arm | Count |
|---|---|
| Delefilcon A, Then Narafilcon B Delefilcon A contact lenses (DAILIES TOTAL1®) worn first, followed by narafilcon B contact lenses (1-DAY ACUVUE® TruEye®). Each product was worn bilaterally (ie, in both eyes) in a daily wear, daily disposable mode for 8 days. | 155 |
| Narafilcon B, Then Delefilcon A Narafilcon B contact lenses (1-DAY ACUVUE® TruEye®) worn first, followed by delefilcon A contact lenses (DAILIES TOTAL1®). Each product was worn bilaterally (ie, in both eyes) in a daily wear, daily disposable mode for 8 days. | 158 |
| Total | 313 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Period 2 - Second 8 Days of Wear | Adverse Event | 2 | 0 |
| Period 2 - Second 8 Days of Wear | Physician Decision | 1 | 0 |
Baseline characteristics
| Characteristic | Delefilcon A, Then Narafilcon B | Narafilcon B, Then Delefilcon A | Total |
|---|---|---|---|
| Age, Continuous | 31.9 years STANDARD_DEVIATION 10 | 32.1 years STANDARD_DEVIATION 8.8 | 32.0 years STANDARD_DEVIATION 9.4 |
| Sex: Female, Male Female | 117 Participants | 120 Participants | 237 Participants |
| Sex: Female, Male Male | 38 Participants | 38 Participants | 76 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 313 | 0 / 313 |
| serious Total, serious adverse events | 0 / 313 | 0 / 313 |
Outcome results
Primary
Overall Comfort
Overall comfort was interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 8 days of wear. Overall comfort was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent. Both eyes contributed to the mean.
Time frame: Day 8
Population: Per-Protocol: All participants completing the study and satisfying all of the inclusion/exclusion criteria, minus protocol deviations as determined by masked review.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Delefilcon A | Overall Comfort | 8.5 Units on a scale | Standard Deviation 1.7 |
| Narafilcon B | Overall Comfort | 8.6 Units on a scale | Standard Deviation 1.5 |
Secondary
End of Day Comfort
End of day comfort was interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 8 days of wear. End of day comfort was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent. Both eyes contributed to the mean.
Time frame: Day 8
Population: Per-Protocol: All participants completing the study and satisfying all of the inclusion/exclusion criteria, minus protocol deviations as determined by masked review.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Delefilcon A | End of Day Comfort | 7.7 Units on a scale | Standard Deviation 2.2 |
| Narafilcon B | End of Day Comfort | 7.9 Units on a scale | Standard Deviation 1.9 |
Secondary
Overall Quality of Vision
Overall quality of vision was interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 8 days of wear. Overall quality of vision was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent. Both eyes contributed to the mean.
Time frame: Day 8
Population: Per-Protocol: All participants completing the study and satisfying all of the inclusion/exclusion criteria, minus protocol deviations as determined by masked review.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Delefilcon A | Overall Quality of Vision | 8.6 Units on a scale | Standard Deviation 1.6 |
| Narafilcon B | Overall Quality of Vision | 8.5 Units on a scale | Standard Deviation 1.6 |