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OpenTrials
Completed

NCT Number: NCT06044948

Clinical Assessment of a Daily Disposable Soft Silicone Hydrogel Contact Lens

The purpose of this study is to assess the clinical performance of DAILIES TOTAL1® spherical soft contact lenses over approximately 1 week of daily wear.

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Key information

Conditions

Refractive Errors Eye Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tallahassee Eye Center, Tallahassee, Florida, United States

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About this study

Subjects will be expected to attend 2 visits (Visit 1 Screen/Baseline/ Dispense; and Visit 2 Week 1 Follow-up/ Exit). The total duration of a subject's participation in the study as well as exposure to the contact lenses will be approximately 1 week (6-8 days of contact lens wear).

Who can participate

Healthy volunteers accepted: Yes

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

Key Inclusion Criteria:

  • Current wearer of commercial spherical soft contact lenses in both eyes with at least 3 months of wearing experience, with a minimum wearing time of 5 days per week and 10 hours per day;
  • Manifest cylinder less than or equal to 0.75 diopter (D) in each eye;
  • Best corrected distance visual acuity better than or equal to 20/25 (Snellen) in each eye.

Key Exclusion Criteria:

  • Current or prior habitual DAILIES TOTAL1 soft contact lens wear in the past 3 months prior to consent;
  • Monovision contact lens wear;
  • 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.

Treatment and study plan

Delefilcon A contact lenses

Device

Daily disposable, silicone hydrogel spherical contact lenses

Other names: DAILIES TOTAL1

Primary outcomes

  1. Distance VA With Study Lenses at Week 1

    Time frame: Week 1

    Visual acuity (VA) was measured for each eye individually with study lenses on eye using letter charts. VA was recorded in Snellen where 20/20 represents normal distance eyesight and 20/15 represents better than normal eyesight. No hypothesis testing was prespecified for this endpoint.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Sep 21, 2023
Registry last updated
Nov 20, 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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