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

NCT ID: NCT02289742

Last Updated: 2016-07-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2015-03-31

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.

Conditions

Refractive Error

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Arm1: Presbyopes

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.

Group Type: OTHER

Nelfilcon A multifocal contact lenses

Intervention Type: DEVICE

Nelfilcon A sphere contact lenses

Intervention Type: DEVICE

Arm2: Astigmats

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.

Group Type: OTHER

Nelfilcon A toric contact lenses

Intervention Type: DEVICE

Nelfilcon A sphere contact lenses

Intervention Type: DEVICE

Interventions

Nelfilcon A multifocal contact lenses

Intervention Type: DEVICE

Nelfilcon A toric contact lenses

Intervention Type: DEVICE

Nelfilcon A sphere contact lenses

Intervention Type: DEVICE

Other Intervention Names

DAILIES® AquaComfort Plus® Multifocal; DACP MF; DAILIES® AquaComfort Plus® Toric; DACP Toric; DAILIES® AquaComfort Plus®; DACP

Eligibility Criteria

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;

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;

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sr. Clinical Manager, Global Med Affairs, Operations

Role: STUDY_DIRECTOR

Alcon Research

Other Identifiers

M-14-010

Identifier Type: -

Identifier Source: org_study_id