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OpenTrials
Completed

NCT Number: NCT05725317

Clinical Performance Assessment of Two Silicone Hydrogel Daily Disposable Contact Lenses

The purpose of this study is to assess the overall clinical performance of a contact lens made with a modified manufacturing process.

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Key information

Conditions

Refractive Errors Eye Diseases Myopia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kindred Optics at Maitland Vision, Maitland, Florida, United States

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About this study

The expected duration of subject participation in the study is approximately 4 days with 2 scheduled visits.

Who can participate

Healthy volunteers accepted: No

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

Key Inclusion Criteria:

  • Successful wearer of spherical soft contact lenses of the same brand in both eyes for a minimum of 5 days per week and 10 hours per day during the past 3 months.
  • Manifest cylinder equal to or less than 0.75 diopter (D) in each eye.
  • Best corrected visual acuity (BCVA) better than or equal to 0.10 logMAR in each eye.
  • Other protocol-specified inclusion criteria may apply.

Key Exclusion Criteria:

  • Any use of topical ocular medications and artificial tear or rewetting drops that would require instillation during study participation.
  • Wearing habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment.
  • Habitual monovision or multifocal contact lens wearers.
  • Other protocol-specified exclusion criteria may apply.

Treatment and study plan

LID220365 contact lens

Device

Investigational delefilcon A spherical contact lens made with a modified manufacturing process

LID006961 contact lens

Device

Commercially available delefilcon A spherical contact lens

Other names: DAILIES TOTAL1®

Primary outcomes

  1. Least Squares Mean Distance Visual Acuity (VA) With Study Lenses at Day 4

    Time frame: Day 4

    VA was assessed for each eye individually at a distance of 4 meters with contact lenses in place using a letter chart. VA was measured in logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with a lower logMAR value indicating better visual acuity.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 13, 2023
Registry last updated
Aug 6, 2024

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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