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OpenTrials
Completed

NCT Number: NCT04908488

Clinical Performance of Two Daily Disposable Toric Soft Contact Lenses

The purpose of this study is to compare the clinical performance of PRECISION1™ for Astigmatism (P1fA) contact lenses with 1-DAY ACUVUE MOIST® for ASTIGMATISM (AMfA) contact lenses.

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Key information

Conditions

Refractive Errors Ametropia Astigmatism Eye Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alcon Investigator 8135, Los Angeles, California, United States

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About this study

Subjects will be expected to attend 4 visits and wear study lenses daily for at least 10 hours per day. 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.

Inclusion criteria

  • Successful wear of toric soft contact lenses in both eyes for a a minimum of 5 days per week and 10 hours per day during the past 3 months.
  • Other protocol-defined inclusion criteria may apply.

Exclusion criteria

  • Habitual PRECISION1 for Astigmatism or 1-DAY ACUVUE MOIST for ASTIGMATISM contact lens wearers.
  • Any spherical monovision and multifocal lens wearers.
  • Routinely sleeping in contact lenses for at least 1 night per week over the last 3 months prior to enrollment.
  • Other protocol-defined exclusion criteria may apply.

Treatment and study plan

verofilcon A toric contact lenses

Device

Soft contact lenses for optical correction of astigmatism

Other names: PRECISION1™ for Astigmatism, P1fA

Etafilcon A toric contact lenses

Device

Soft contact lenses for optical correction of astigmatism

Other names: 1-DAY ACUVUE MOIST® for ASTIGMATISM, AMfA

Primary outcomes

  1. Least Squares Mean 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.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jun 1, 2021
Registry last updated
Oct 18, 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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