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

Alcon

Status: Completed

Conditions: Refractive Error

Treatments: Device: Nelfilcon A multifocal contact lenses; Device: Nelfilcon A toric contact lenses; Device: Nelfilcon A sphere contact lenses

Study type: Interventional

Funder types: Industry

Identifiers

NCT02289742

M-14-010

Details and patient eligibility

About

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.

Full description

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

Enrollment: 48 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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48 participants in 2 patient groups

Arm1: Presbyopes

Other group

Description:

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.

Treatment:

Device: Nelfilcon A sphere contact lenses

Device: Nelfilcon A multifocal contact lenses

Arm2: Astigmats

Other group

Description:

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.

Treatment:

Device: Nelfilcon A sphere contact lenses

Device: Nelfilcon A toric contact lenses