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OpenTrials
Completed

NCT Number: NCT04980456

Clinical Assessment of Two Daily Wear Monthly Replacement Soft Silicone Hydrogel Contact Lenses

The purpose of this study is to compare the clinical performance of TOTAL30 contact lenses with Biofinity contact lenses over 30 days of daily wear.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alcon Investigator 8135, Los Angeles, California, United States

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About this study

Subjects will wear two products and be expected to attend 4 office visits. The individual duration of participation will be approximately 65 days, which includes approximately 30 days of exposure to the test product and approximately 30 days of exposure to the comparator product.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Able to understand and sign an approved Informed Consent form;
  • Willing and able to attend all scheduled study visits as required by the protocol;
  • Currently wearing any commercial spherical weekly/monthly soft contact lenses in both eyes for at least 3 months, minimum 5 days per week, 10 hours per day;
  • Manifest cylinder less than or equal to 0.75 diopter (D) in each eye;
  • Willing to stop wearing habitual contact lenses for the duration of study participation.
  • Other protocol-defined inclusion criteria may apply.

Exclusion criteria

  • Any eye condition that contraindicates contact lens wear, as determined by the Investigator;
  • Any use of systemic or ocular medicine that contraindicates contact lens wear, as determined by the Investigator;
  • Ocular or intraocular surgery (excluding placement of punctal plugs) within the previous 12 months or planned during the study;
  • Any use of topical ocular medications and artificial tear or rewetting drops that would require instillation during contact lens wear;
  • Current or prior Biofinity contact lens wear in the past 3 months prior to consent.
  • Other protocol-defined exclusion criteria may apply.

Treatment and study plan

Lehfilcon A contact lenses

Device

Investigational silicone hydrogel contact lenses

Other names: TOTAL30

Comfilcon A contact lenses

Device

Commercially available silicone hydrogel contact lenses

Other names: CooperVision® Biofinity®, Biofinity

CLEAR CARE

Device

Hydrogen peroxide-based cleaning and disinfecting solution

Primary outcomes

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

    Time frame: Day 30, each study product

    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
Jul 28, 2021
Registry last updated
Jan 6, 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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