DAILIES® AquaComfort Plus® Multifocal (MF) - Comparative Assessment of Visual Performance

Study Overview
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Brief Summary
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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.

Official Title
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Comparative Assessment of Visual Performance Between DAILIES® AquaComfort Plus® (DACP) Multifocal (MF) and PROCLEAR 1 Day Multifocal (PROCLEAR 1D MF)

Conditions
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Presbyopia

Intervention / Treatment
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* Device: DACP MF
* Device: PROCLEAR 1D MF


Participation Criteria
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Eligibility Criteria
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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 exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 41 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: DACP MF, then PROCLEAR 1D MF<br>DACP MF (nelfilcon A) multifocal contact lenses worn in Period 1, followed by PROCLEAR 1D MF (omafilcon A) multifocal contact lenses worn in Period 2. Both products were worn bilaterally (in both eyes) for 5 ±1 days in a daily wear, daily disposable modality. | Device: DACP MF<br>* Nelfilcon A multifocal contact lenses<br>* Other names: Nelfilcon A;Device: PROCLEAR 1D MF<br>* Omafilcon A multifocal contact lenses<br>* Other names: Omafilcon A;|
| Other: PROCLEAR 1D MF, then DACP MF<br>PROCLEAR 1D MF (omafilcon A) multifocal contact lenses worn in Period 1, followed by DACP MF (nelfilcon A) multifocal contact lenses worn in Period 2. Both products were worn bilaterally (in both eyes) for 5 ±1 days in a daily wear, daily disposable modality. | Device: DACP MF<br>* Nelfilcon A multifocal contact lenses<br>* Other names: Nelfilcon A;Device: PROCLEAR 1D MF<br>* Omafilcon A multifocal contact lenses<br>* Other names: Omafilcon A;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Day 5, each product | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Day 5, each product | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Visual Performance