Tear Film Evaluation of Dailies® AquaComfort Plus® Multifocal and Toric

Study Overview
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Brief Summary
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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
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Two population groups (presbyopes and astigmats) will be enrolled in the study.

Official Title
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Characterization of Pre-Lens Tear Film Stability of Daily Disposable Multifocal and Toric Contact Lenses Using Ring Mire Projection

Conditions
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Refractive Error

Intervention / Treatment
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* Device: Nelfilcon A multifocal contact lenses
* Device: Nelfilcon A toric contact lenses
* Device: Nelfilcon A sphere contact lenses


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must sign an informed consent document; Adapted, current soft contact lens wearer with either: A spectacle add between +0.50 and +2.50 (inclusive) [Presbyopes group] 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 exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 18 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: Arm1: Presbyopes<br>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. | Device: Nelfilcon A multifocal contact lenses<br> <br> * Other names: DACP MF;Device: Nelfilcon A sphere contact lenses<br> <br> * Other names: DACP;|
| Other: Arm2: Astigmats<br>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. | Device: Nelfilcon A toric contact lenses<br> <br> * Other names: DACP Toric;Device: Nelfilcon A sphere contact lenses<br> <br> * Other names: DACP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Hour 12, each product | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Hour 8, each product | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tear film stability, Dailies AquaComfort Plus® Multifocal (DACP MF), Dailies AquaComfort Plus® Toric (DACP Toric), Non-Invasive Keratograph Break-Up Time (NIK-BUT)