Refractive Error
Conditions
Keywords
Dailies AquaComfort Plus® Multifocal (DACP MF), Dailies AquaComfort Plus® Toric (DACP Toric), tear film stability, Non-Invasive Keratograph Break-Up Time (NIK-BUT)
Brief summary
The purpose of this study is to evaluate the pre lens tear film characteristics of DAILIES® Aqua Comfort Plus® Multifocal (DACP MF) and Toric (DACP Toric) compared to DAILIES® Aqua Comfort Plus® Sphere (DACP) daily disposable contact lenses over 12 hours of lens wear.
Detailed description
Two population groups (presbyopes and astigmats) will be enrolled in the study.
Interventions
DEVICENelfilcon A sphere 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 No maximum
Healthy volunteers
No
Inclusion criteria
* Must sign an informed consent document; * Adapted, current soft contact lens wearer with either: 1. A spectacle add between +0.50 and +2.50 (inclusive) \[Presbyopes group\] 2. A spherical correction of an astigmatism up to 20% of the amount of the sphere \[Astigmats group\]; * Contact lens prescription in the power range specified in the protocol; * Vision correctable to 0.2 logMAR (logarithmic minimal angle for resolution) or better in each eye at distance with pre-study lenses or manifest refraction at Visit 1; * Willing to wear study lenses up to 12 hours and attend all study visits; * Can be successfully fitted with study lenses; * Other protocol-specified inclusion criteria may apply.
Exclusion criteria
* Any ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear; * Use of systemic or ocular medications for which contact lens wear could be contraindicated as determined by the investigator; * Use of artificial tears and rewetting drops during the study; * Monocular (only 1 eye with functional vision) or fit with only 1 lens; * Any abnormal ocular condition observed during the Visit 1 slit-lamp examination; * History of herpetic keratitis, ocular surgery, or irregular cornea; * Pregnant or lactating; * Unstable tear film with a NIK-BUT value below 8 seconds in either eye without lenses; * Participation in any clinical study within 30 days of Visit 1; * Other protocol-specified
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects With Wettability Grade of 2 or 3 After 12 Hours of Wear | Hour 12, each product | A video was made to capture a visual demonstration of tear film characteristics in between blinks. The investigator graded contact lens surface wettability using a scale from 0 (fully wettable) to 3 (clearly visible distortions) at 5, 10, 15, 20 and 25 seconds post-blink by region (central, superior, nasal, inferior, and temporal). Three independent measurements (3 blinks) were carried out. An average was taken over the 3 measurements, 5 regions, and 5 time points. One eye contributed to the analysis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects With Wettability Grade of 2 or 3 After 8 Hours of Wear | Hour 8, each product | A video was made to capture a visual demonstration of tear film characteristics in between blinks. The investigator graded contact lens surface wettability using a scale from 0 (fully wettable) to 3 (clearly visible distortions) at 5, 10, 15, 20 and 25 seconds post-blink by region (central, superior, nasal, inferior, and temporal). Three independent measurements (3 blinks) were carried out. An average was taken over the 3 measurements, 5 regions, and 5 time points. One eye contributed to the analysis. |
Participant flow
Recruitment details
Subjects were recruited from 1 study center located in Germany.
Pre-assignment details
Of the 48 enrolled subjects, 3 were discontinued as screen failures prior to randomization. This reporting group includes all randomized subjects (45).
Participants by arm
| Arm | Count |
|---|---|
| Presbyopes Nelfilcon A contact lenses (multifocal and sphere) worn as randomized in a crossover design during Periods 1 and 2, with nelfilcon A sphere contact lenses in Period 3. Each product worn bilaterally (in both eyes) for 12 hours. | 22 |
| Astigmats Nelfilcon A contact lenses (toric and sphere) worn as randomized in a crossover design during Periods 1 and 2, with nelfilcon A sphere contact lenses in Period 3. Each product worn bilaterally (in both eyes) for 12 hours. | 21 |
| Total | 43 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| First Wear Period | Adverse Event | 0 | 0 | 1 | 0 |
| First Wear Period | Adverse event prior to treatment | 0 | 1 | 0 | 0 |
| First Wear Period | Other prior to treatment | 0 | 0 | 0 | 1 |
| Third Wear Period | Adverse Event | 0 | 1 | 0 | 0 |
| Third Wear Period | Reason not given | 0 | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Presbyopes | Astigmats | Total |
|---|---|---|---|
| Age, Continuous | 51.7 years STANDARD_DEVIATION 8.1 | 25.8 years STANDARD_DEVIATION 4.5 | 39.0 years STANDARD_DEVIATION 14.6 |
| Region of Enrollment Germany | 22 participants | 21 participants | 43 participants |
| Sex: Female, Male Female | 16 Participants | 16 Participants | 32 Participants |
| Sex: Female, Male Male | 6 Participants | 5 Participants | 11 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 | EG006 affected / at risk |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 48 | 0 / 22 | 0 / 22 | 0 / 22 | 0 / 21 | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 48 | 0 / 22 | 0 / 22 | 0 / 22 | 0 / 21 | 0 / 20 | 0 / 20 |
Outcome results
Primary
Percentage of Subjects With Wettability Grade of 2 or 3 After 12 Hours of Wear
A video was made to capture a visual demonstration of tear film characteristics in between blinks. The investigator graded contact lens surface wettability using a scale from 0 (fully wettable) to 3 (clearly visible distortions) at 5, 10, 15, 20 and 25 seconds post-blink by region (central, superior, nasal, inferior, and temporal). Three independent measurements (3 blinks) were carried out. An average was taken over the 3 measurements, 5 regions, and 5 time points. One eye contributed to the analysis.
Time frame: Hour 12, each product
Population: This analysis population includes all randomized and exposed subjects with data at visit.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Presbyopes / Multifocal | Percentage of Subjects With Wettability Grade of 2 or 3 After 12 Hours of Wear | 55.8 percentage of subjects |
| Presbyopes / Sphere | Percentage of Subjects With Wettability Grade of 2 or 3 After 12 Hours of Wear | 47.2 percentage of subjects |
| Astigmats / Toric | Percentage of Subjects With Wettability Grade of 2 or 3 After 12 Hours of Wear | 46.5 percentage of subjects |
| Astigmats / Sphere | Percentage of Subjects With Wettability Grade of 2 or 3 After 12 Hours of Wear | 49.5 percentage of subjects |
Secondary
Percentage of Subjects With Wettability Grade of 2 or 3 After 8 Hours of Wear
A video was made to capture a visual demonstration of tear film characteristics in between blinks. The investigator graded contact lens surface wettability using a scale from 0 (fully wettable) to 3 (clearly visible distortions) at 5, 10, 15, 20 and 25 seconds post-blink by region (central, superior, nasal, inferior, and temporal). Three independent measurements (3 blinks) were carried out. An average was taken over the 3 measurements, 5 regions, and 5 time points. One eye contributed to the analysis.
Time frame: Hour 8, each product
Population: This analysis population includes all randomized and exposed subjects with data at visit.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Presbyopes / Multifocal | Percentage of Subjects With Wettability Grade of 2 or 3 After 8 Hours of Wear | 60.8 percentage of subjects |
| Presbyopes / Sphere | Percentage of Subjects With Wettability Grade of 2 or 3 After 8 Hours of Wear | 46.3 percentage of subjects |
| Astigmats / Toric | Percentage of Subjects With Wettability Grade of 2 or 3 After 8 Hours of Wear | 34.3 percentage of subjects |
| Astigmats / Sphere | Percentage of Subjects With Wettability Grade of 2 or 3 After 8 Hours of Wear | 33.3 percentage of subjects |