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OpenTrials
Completed

NCT Number: NCT05010512

Clinical Performance of Two Commercial, Daily Disposable Contact Lenses

The purpose of this study is to compare the clinical performance of DAILIES TOTAL1 ( DT1) contact lenses with Infuse contact lenses.

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Key information

Conditions

Refractive Errors Ametropia Eye Diseases Myopia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alcon Investigator 6355, Orlando, Florida, United States

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About this study

Subjects will wear two products and be expected to attend 3 office visits. The individual duration of participation will be approximately 3 weeks, which includes 16 to 22 days of lens wear.

Who can participate

Healthy volunteers accepted: No

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

Key Inclusion Criteria:

  • Habitually wears soft contact lenses in both eyes at least 5 days per week and at least 10 hours per day;
  • At least 3 months of contact lens wearing experience;
  • Less than or equal to 0.75 diopter (D) astigmatism in each eye;
  • Best Corrected Visual Acuity (BCVA) better than or equal to 20/25 in each eye.
  • Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

  • Current/previous DAILIES TOTAL1 and/or Infuse habitual lens wearer;
  • Monovision and/or multifocal lens wearer;
  • Routinely sleeps in habitual contact lenses.
  • Other protocol-defined exclusion criteria may apply.

Treatment and study plan

Delefilcon A contact lenses

Device

Commercially available silicone hydrogel contact lenses used as indicated

Other names: DAILIES TOTAL1®, DT1

Kalifilcon A contact lenses

Device

Commercially available silicone hydrogel contact lenses used as indicated

Other names: Bausch + Lomb INFUSE™, Infuse

Primary outcomes

  1. Least Squares Mean Distance VA (logMAR) With Study Lenses

    Time frame: Day 8 (-0/+3), 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
Aug 18, 2021
Registry last updated
Nov 8, 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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