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

Not Applicable

Completed

Interventions: Device: Nelfilcon A toric contact lenses
Device: Nelfilcon A multifocal contact lenses
Device: Nelfilcon A sphere contact lenses

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.

Recruitment & Eligibility

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 exclusion criteria may apply.

Arm && Interventions

Group	Intervention	Description
Arm1: Presbyopes	Nelfilcon A sphere contact lenses	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.
Arm2: Astigmats	Nelfilcon A sphere contact lenses	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.
Arm2: Astigmats	Nelfilcon A toric contact lenses	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.
Arm1: Presbyopes	Nelfilcon A multifocal contact lenses	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.