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OpenTrials
Completed

NCT Number: NCT05138783

Clinical Performance of Two Daily Disposable Soft Contact Lenses

The purpose of this study is to compare the clinical performance of PRECISION1 contact lenses with Biotrue contact lenses.

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Key information

Conditions

Refractive Errors Eye Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kindred Optics at Maitland Vision, Maitland, Florida, United States

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About this study

Subjects will be expected to attend 3 visits. Subjects will be expected to wear their study contact lenses every day for at least 10 hours per day over an 8-day period for each study lens type. The total duration of a subject's participation in the study will be up to 22 days.

Who can participate

Healthy volunteers accepted: No

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

Key Inclusion Criteria:

  • Successful wear of spherical soft contact lenses with at least 3 months wearing experience, with a minimum wearing time of 5 days per week and 10 hours per day.
  • Willing to wear habitual spectacles for vision correction when study lenses are not worn, as needed.
  • Willing to wear contact lenses for at least 16 hours on the day prior to Visit 2 and the day prior to Visit 3.
  • Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

  • Participation in a clinical trial within the previous 30 days or currently enrolled in any clinical trial.
  • Habitual PRECISION1, Biotrue, and DAILIES TOTAL1 contact lens wear.
  • Monovision and multifocal lens wear.
  • Other protocol-defined exclusion criteria may apply.

Treatment and study plan

Verofilcon A contact lenses

Device

Spherical soft contact lenses for daily disposable wear

Other names: PRECISION1™

Nesofilcon A contact lenses

Device

Spherical soft contact lenses for daily disposable wear

Other names: Biotrue® ONEday

Primary outcomes

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

    Time frame: Day 8 (-0/+3 days), each study lens type

    Visual Acuity (VA) was collected for each eye individually with study lenses in place using a letter chart. VA was measured in logarithm of the minimum angle of resolution (logMAR). A logMAR value of 0 corresponds to 20/20 Snellen 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
2022
Primary completion
2022
Study completion
2022
First posted
Dec 1, 2021
Registry last updated
Apr 18, 2023

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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