Presbyopia
Conditions
Keywords
Visual Performance
Brief summary
The purpose of this study is to evaluate the visual performance of DACP MF and PROCLEAR 1D MF daily disposable contact lenses in an established presbyopic population.
Interventions
DEVICEDACP MF
Nelfilcon A multifocal contact lenses
DEVICEPROCLEAR 1D MF
Omafilcon A multifocal contact lenses
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
41 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Must sign an informed consent; * Adapted soft contact lens wearer; * Vision correctable to 20/30 \[(0.2 logMAR (logarithm of the minimum angle of resolution)\] or better in each eye at distance; * Willing to wear lenses every day or for at least 5 days per week, 6 hours per day; * Other protocol-specified inclusion criteria may apply.
Exclusion criteria
* Currently wearing multifocal contact lenses; * Currently wearing monovision; * Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear; * Use of systemic or ocular medications which could contraindicate contact lens wear; * Eye injury or surgery within 12 weeks prior to enrollment; * Prior refractive surgery; * Monocular (only 1 eye with functional vision) or fit with only 1 lens; * Other protocol-specified
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Stereoacuity at Near After 5+/-1 Days of Contact Lens Wear | Day 5, each product | Stereoacuity (SA) is the ability to detect differences in distance (depth perception). Near SA was measured at a distance of 40 cm using the Howard-Dolman system. A lower SA value indicates better depth perception. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Area of Focus Under the Mean Defocus Curve After 5 +/- 1 Days of Contact Lens Wear | Day 5, each product | Visual acuity was measured with contact lenses in place using an Early Treatment Diabetic Retinopathy Study (ETDRS) high contrast logMAR chart under well-lit conditions. Trial Lenses of different spherical powers (+2.00 diopter to -5.00 diopter) were placed in front of the eyes to produce varying levels of defocus, and logMAR acuity at each defocus value was recorded. The area under the defocus curve (AUC) was calculated via the trapezoidal rule for the entire study population by treatment using a 0.3 logMAR threshold for intermediate from -2.00 D (50cm) to -0.50 D (2m) and near from -4.00 D (25cm) to -2.00 D (50cm). A higher value indicates a bigger area of focus. |
Participant flow
Recruitment details
Participants were recruited from one investigational center located in Spain.
Pre-assignment details
This reporting group includes all enrolled participants (70).
Participants by arm
| Arm | Count |
|---|---|
| DACP MF, Then PROCLEAR 1D MF Nelfilcon A contact lenses were worn in Period 1, followed by omafilcon A contact lenses in Period 2. | 36 |
| PROCLEAR 1D MF, Then DACP MF Omafilcon A contact lenses were worn in Period 1, followed by nelfilcon A contact lenses in Period 2. | 34 |
| Total | 70 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Period 2 (5 Days) | Withdrawal by Subject | 0 | 1 |
| Pre-Treatment Period | Withdrawal by subject prior to treatment | 0 | 1 |
Baseline characteristics
| Characteristic | DACP MF, Then PROCLEAR 1D MF | PROCLEAR 1D MF, Then DACP MF | Total |
|---|---|---|---|
| Age, Continuous | 51.7 years STANDARD_DEVIATION 4.67 | 50.4 years STANDARD_DEVIATION 3.88 | 51.1 years STANDARD_DEVIATION 4.32 |
| Age, Customized 41-50 years | 15 participants | 20 participants | 35 participants |
| Age, Customized 51-60 years | 20 participants | 13 participants | 33 participants |
| Age, Customized 61-65 years | 1 participants | 1 participants | 2 participants |
| Sex: Female, Male Female | 22 Participants | 26 Participants | 48 Participants |
| Sex: Female, Male Male | 14 Participants | 8 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 69 | 0 / 69 |
| serious Total, serious adverse events | 0 / 69 | 0 / 69 |
Outcome results
Primary
Mean Stereoacuity at Near After 5+/-1 Days of Contact Lens Wear
Stereoacuity (SA) is the ability to detect differences in distance (depth perception). Near SA was measured at a distance of 40 cm using the Howard-Dolman system. A lower SA value indicates better depth perception.
Time frame: Day 5, each product
Population: Intention to treat participants with non-missing observations
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Proclear 1 Day MF | Mean Stereoacuity at Near After 5+/-1 Days of Contact Lens Wear | 40.6 arcsec | Standard Deviation 11.67 |
| DACP MF | Mean Stereoacuity at Near After 5+/-1 Days of Contact Lens Wear | 30.7 arcsec | Standard Deviation 8.67 |
Secondary
Mean Area of Focus Under the Mean Defocus Curve After 5 +/- 1 Days of Contact Lens Wear
Visual acuity was measured with contact lenses in place using an Early Treatment Diabetic Retinopathy Study (ETDRS) high contrast logMAR chart under well-lit conditions. Trial Lenses of different spherical powers (+2.00 diopter to -5.00 diopter) were placed in front of the eyes to produce varying levels of defocus, and logMAR acuity at each defocus value was recorded. The area under the defocus curve (AUC) was calculated via the trapezoidal rule for the entire study population by treatment using a 0.3 logMAR threshold for intermediate from -2.00 D (50cm) to -0.50 D (2m) and near from -4.00 D (25cm) to -2.00 D (50cm). A higher value indicates a bigger area of focus.
Time frame: Day 5, each product
Population: Intention to treat participants with non-missing observations
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Proclear 1 Day MF | Mean Area of Focus Under the Mean Defocus Curve After 5 +/- 1 Days of Contact Lens Wear | for the Near Region | 0.04 diopter*logMar | Standard Deviation 0.051 |
| Proclear 1 Day MF | Mean Area of Focus Under the Mean Defocus Curve After 5 +/- 1 Days of Contact Lens Wear | for the Intermediate Region | 0.17 diopter*logMar | Standard Deviation 0.092 |
| DACP MF | Mean Area of Focus Under the Mean Defocus Curve After 5 +/- 1 Days of Contact Lens Wear | for the Near Region | 0.07 diopter*logMar | Standard Deviation 0.061 |
| DACP MF | Mean Area of Focus Under the Mean Defocus Curve After 5 +/- 1 Days of Contact Lens Wear | for the Intermediate Region | 0.21 diopter*logMar | Standard Deviation 0.077 |