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OpenTrials
Completed

NCT Number: NCT04844281

Wear Experience With Daily Toric Contact Lenses Over a Long Day

This study is evaluating the wear experience of a daily toric contact lens after 10, 12, 14, and 16 hours of lens wear.

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Key information

Conditions

Contact Lens Astigmatism of Both Eyes

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Ohio State University

Columbus, Ohio, 43210, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Must be current soft toric contact lens wearers with longs days of lens wear within the parameters of Precision1® lenses available.
  • Distance visual acuity of 20/25 or better with current lenses.
  • Recent eye exam in the last year.
  • Good general health (defined by medication use that has not changed within the last month and the absence of medical conditions or treatments that are deemed confounding to the data as determined by the PI).
  • Ability to give informed consent.
  • Must have a working smart phone or device and be willing to receive and respond to texts and/or emails.
  • Willing to spend time for the study, which includes three in-person study visits (with a possible fourth visit if needed), wearing contact lenses on days between study visits, and responding to communications on a smart phone or other electronic device on five weekdays between Visits 2 and 3.

Exclusion criteria

  • Current ocular inflammation or infection as assessed by the study investigator.
  • Currently pregnant, lactating, or planning to become pregnant during the course of the study.

Treatment and study plan

Precision1® Daily Disposable Toric Contact Lens

Device

Soft, toric contact lens used to correct distance vision and astigmatism.

Primary outcomes

  1. Subjective Vision in Contact Lenses Assessed Using a 1 to 10 Scale After 16 Hours of Wear in One Day (After up to 14 Days of Wear)

    Time frame: Assessment is taken at the 16 hour of wear time point in a single day, after up to 14 days of wear.

    1 describes poor experience, and 10 describes excellent experience.

  2. Subjective Comfort on a 1-10 Scale After 16 Hours of Wear in One Day (After up to 14 Days of Wear)

    Time frame: Taken at the 16 hour of wear time point in a single day, after up to 14 days of wear Up to 14 days

    1 describes poor experience, and 10 describes excellent experience.

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Collaborators

  • Alcon Research

Registry information

Official study title

Evaluation of Wear Experience With PRECISION1® Toric Contact Lenses on Long Lens Wear Days

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Apr 14, 2021
Registry last updated
Nov 29, 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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