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Completed

NCT Number: NCT02289742

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nelfilcon A multifocal contact lenses

Device

Other names: DAILIES® AquaComfort Plus® Multifocal, DACP MF

Nelfilcon A toric contact lenses

Device

Other names: DAILIES® AquaComfort Plus® Toric, DACP Toric

Nelfilcon A sphere contact lenses

Device

Other names: DAILIES® AquaComfort Plus®, DACP

Primary outcomes

  1. Percentage of Subjects With Wettability Grade of 2 or 3 After 12 Hours of Wear

    Time frame: 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 outcomes

  1. Percentage of Subjects With Wettability Grade of 2 or 3 After 8 Hours of Wear

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Nov 13, 2014
Registry last updated
Jul 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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