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Completed

NCT Number: NCT04942925

Clinical Comparison of Two Daily Disposable Contact Lenses - Pilot Study 3

The purpose of this study is to evaluate the overall performance of PRECISION1™ contact lenses when compared to INFUSE™ contact lenses.

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Key information

Conditions

Myopia Ametropia Eye Diseases Refractive Errors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alcon Investigator 6565, Maitland, Florida, United States

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About this study

The expected duration of subject participation in the study is up to 24 days with 3 scheduled visits.

Who can participate

Healthy volunteers accepted: No

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

Key Inclusion Criteria:

  • Able to understand and sign an Informed Consent Form that been approved by an Institutional Review Board.
  • Successful wear of spherical soft contact lenses in both eyes for a minimum of 5 days per week and 10 hours per day during the past 3 months.
  • Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

  • Current/previous PRECISION1 or INFUSE contact lens wearer.
  • Any eye condition or use of medication that contraindicates contact lens wear, as determined by the investigator.
  • Routinely sleeps in contact lenses.
  • Other protocol-defined exclusion criteria may apply.

Treatment and study plan

Verofilcon A contact lenses

Device

Commercially available silicone hydrogel contact lenses for daily disposable wear

Other names: PRECISION1™

Kalifilcon A contact lenses

Device

Commercially available silicone hydrogel contact lenses for daily disposable wear

Other names: Bausch + Lomb INFUSE™

Primary outcomes

  1. Distance VA (logMAR) With Study Lenses

    Time frame: Day 8 (-0/+3 days), 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. No inferential testing was pre-specified for this endpoint.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jun 29, 2021
Registry last updated
Sep 7, 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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