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

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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:

  • 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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