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OpenTrials
Completed

NCT Number: NCT05039112

Clinical Comparison of 2 Daily Disposable Toric Soft Contact Lenses

The purpose of this study to evaluate the overall performance of PRECISION1™ for Astigmatism contact lenses with MyDay® Toric contact lenses.

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Key information

Conditions

Refractive Errors Astigmatism Eye Diseases

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

Subjects will be expected to attend 4 visits and wear study lenses daily for approximately 10 hours per day. On the day prior to the Week 1 Follow-up visit of each crossover period, subjects will be asked to wear the respective study lens for at least 16 hours. The expected duration of subject participation in the study is approximately 3 weeks.

Who can participate

Healthy volunteers accepted: No

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

Key Inclusion Criteria:

  • Successful wear of toric soft contact lenses in both eyes for a minimum of 5 days per week and 10 hours per day during the past 3 months.
  • Willing to wear study contact lenses for at least 16 hours on the day prior to the Week 1 Follow up visit of each lens type.
  • Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

  • Current/previous wear of PRECISION1 for Astigmatism or MyDay Toric contact lenses.
  • Current wear of spherical contact lenses.
  • Wears habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week).
  • 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, used as indicated

Other names: PRECISION1 for Astigmatism, P1fA

Stenfilcon A toric contact lenses

Device

Soft contact lenses for optical correction of astigmatism, used as indicated

Other names: MyDay Toric

Primary outcomes

  1. Percent of lenses with axis orientation within ±30 degrees inclusive from the intended axis, 10 minutes after lens insertion

    Time frame: Day 1, 10 minutes after lens insertion, each product

    Axis orientation (orientation of the scribe mark) will be assessed by slit lamp examination and recorded as deviations from intended axis.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Sep 9, 2021
Registry last updated
Dec 7, 2021

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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