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OpenTrials
Completed

NCT Number: NCT05483127

Clinical Comparison of Two Daily Disposable Toric Soft Contact Lenses

The primary purpose of this study is to demonstrate noninferiority in the visual acuity at distance when wearing PRECISION1™ for Astigmatism (P1fA) soft contact lenses compared to another commercially available, soft toric contact lens, MyDay® toric (MDT).

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Key information

Conditions

Astigmatism Ametropia Eye Diseases Myopia Refractive Errors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kurata Eyecare Center, Los Angeles, California, United States

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About this study

Study participants will wear each study lens type in 1 of 2 randomized, crossover sequences. Participants will be expected to attend 4 visits and wear study lenses for at least 10 hours per day. The total duration of an individual's participation in the study will be up to 28 days.

Who can participate

Healthy volunteers accepted: No

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

Key Inclusion Criteria:

  • Successful wearers of toric soft contact lenses in both eyes with at least 3 months wearing experience, with a minimum wearing time of 5 days per week and 10 hours per day.
  • Able to wear contact lenses within a range of sphere & cylinder power and axes.
  • Willing to NOT use rewetting/lubricating drops at any time during the study.
  • Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

  • Current or previous P1fA and MDT habitual lens wearers.
  • Monovision and multifocal lens wearers.
  • Participation of the subject in a clinical trial within the previous 30 days or currently enrolled in any clinical trial.
  • Other protocol-defined exclusion criteria may apply.

Treatment and study plan

Verofilcon A toric soft contact lenses

Device

Soft contact lenses for optical correction of ametropia and astigmatism

Other names: PRECISION1™ for Astigmatism, P1fA

Stenfilcon A toric soft contact lenses

Device

Soft contact lenses for optical correction of ametropia and astigmatism

Other names: MyDay® toric soft contact lenses, MDT

Primary outcomes

  1. Least Squares Means Distance Visual Acuity With Study Lenses at Week 1

    Time frame: Day 8 of each study lens type worn during the corresponding crossover period

    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. LogMAR typically ranges from -0.3 (20/10 vision on the Snellen chart) to 1 (20/200 vision). A logMAR acuity of 0.0 corresponds to 20/20 Snellen (normal distance 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
2022
Primary completion
2022
Study completion
2022
First posted
Aug 1, 2022
Registry last updated
Nov 2, 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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