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OpenTrials
Completed

NCT Number: NCT04865354

Clinical Comparison of Two Daily Disposable Contact Lenses

The purpose of this study is to compare the clinical performance of PRECISION1™ contact lenses to Clariti® 1 day 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

Alcon Investigator 8106, San Francisco, California, United States

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About this study

Subjects will be expected to attend 3 study visits and wear the study lenses daily for at least 10 hours per day. On the day prior to Visits 2 and 3, subjects will be expected to wear the study lenses for at least 16 hours. The total duration of subject participation 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 wearer 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.
  • Possess spectacles and 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 one of the days (day prior to each week 1 visit).
  • Other protocol-specified inclusion criteria may apply.

Key Exclusion Criteria:

  • Habitual PRECISION1, Clariti 1-Day, and DAILIES TOTAL1 contact lens wearers.
  • Any monovision and multifocal lens wearers.
  • Other protocol-specified exclusion criteria may apply.

Treatment and study plan

Verofilcon A contact lenses

Device

Spherical soft contact lenses for daily disposable wear

Other names: PRECISION1

Somofilcon A contact lenses

Device

Spherical soft contact lenses for daily disposable wear

Other names: Clariti 1-Day

Primary outcomes

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

    Time frame: Day 8, each study lens type

    Distance visual acuity (VA) was assessed with study lenses in place. VA was collected for each eye separately using logarithmic of the Minimum Angle of Resolution (logMAR) charts. A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity (normal visual acuity), with a negative value denoting better than 20/20 visual acuity.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Apr 29, 2021
Registry last updated
Jul 6, 2022

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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