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OpenTrials
Completed

NCT Number: NCT03628599

Two Daily Disposable Contact Lenses in Symptomatic Patients

The purpose of this study is to evaluate the performance of DAILIES TOTAL1® and ACUVUE OASYS® 1-DAY and with respect to visual acuity in a symptomatic study population of monthly or bi-weekly replacement lens wearers.

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Key information

Conditions

Myopia Eye Diseases Refractive Errors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alcon Investigative Site, Bloomington, Illinois, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Able to understand and must sign an IRB-approved informed consent form;
  • Soft contact lens wearers in both eyes during the past 3 months;
  • Best-corrected visual acuity (BCVA) 20/25 or better in each eye;
  • Willing to wear study lenses at least 3 days per week and at least 8 hours per day;
  • Willing to stop wearing habitual contact lenses for the duration of study participation.

Exclusion criteria

  • Infection, inflammation, abnormality, condition, disease, surgery, or use of medications, as specified in the protocol;
  • Intolerance, hypersensitivity, or allergy to any component of the study products;
  • Wearing habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment;
  • Monocular (only one eye with functional vision).

Treatment and study plan

Delefilcon A contact lenses

Device

Water Gradient silicon hydrogel daily disposable contact lenses

Other names: DAILIES TOTAL1® (DT1)

Senofilcon A contact lenses

Device

Silicon hydrogel daily disposable contact lenses with HydraLuxe™ Technology

Other names: ACUVUE OASYS® 1-DAY

Primary outcomes

  1. Monocular Corrected Distance Visual Acuity (VA)

    Time frame: Week 4

    Monocular (each eye) corrected (with spectacles or other visual corrective devices) VA was performed under dimmed room illumination using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart at distance. VA was reported in logMAR ("logarithm of the minimum angle of resolution"), with a lower logMAR indicating better visual acuity. No inferential hypotheses was planned for this endpoint.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Aug 14, 2018
Registry last updated
Jul 5, 2019

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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