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

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

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.

Two population groups (presbyopes and astigmats) will be enrolled in the study.

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.