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OpenTrials
Completed

NCT Number: NCT04013789

Comparison of Two Daily Disposable Lenses

The purpose of this study was to compare the clinical performance of the new DAILIES® AquaComfort PLUS® FreshTech (DACP FreshTech) contact lenses to an already marketed daily disposable contact lens, DAILIES® AquaComfort PLUS® (DACP).

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Key information

Conditions

Refractive Ametropia Asthenopia Eye Diseases Myopia Refractive Errors

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alcon Investigative Site

Bloomington, Indiana, 47405, United States

About this study

Subjects attended 4 scheduled visits for an expected duration of participation of 3 weeks.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • At least 3 months of soft contact lens wearing experience;
  • Wears habitual lenses at least 5 days per week and at least 8 hours per day;
  • Uses digital devices (computer, tablet, and/or smart phone) for an average of 4 hours per day;
  • Experiences eye fatigue at least once per week attributable to digital device use with habitual lenses;
  • Is willing to NOT use rewetting/lubricating drops during the period of study product exposure;
  • Other protocol-specified inclusion criteria may apply.

Exclusion criteria

  • Routinely sleeps in contact lenses;
  • Known pregnancy at time of enrollment;
  • Binocular vision issues or issues of eye alignment;
  • Any eye infection, inflammation, disease or abnormality that contraindicates contact lens wear;
  • Use of medications as specified in the protocol;
  • Ocular surgery within the past 12 months;
  • Other protocol-specified exclusion criteria may apply.

Treatment and study plan

DACP FreshTech contact lenses

Device

Nelfilcon A soft contact lenses with a modified lens design

Other names: DAILIES® AquaComfort PLUS® FreshTech

DACP contact lenses

Device

Nelfilcon A soft contact lenses

Other names: DAILIES® AquaComfort PLUS®

Primary outcomes

  1. Mean Distance Visual Acuity (VA) With Study Lenses

    Time frame: Week 1, each product

    VA was assessed at a distance of 4 meters using a letter chart and was measured in logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with a lower logMAR value indicating better visual acuity.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jul 10, 2019
Registry last updated
Nov 24, 2020

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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