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OpenTrials
Completed

NCT Number: NCT04476784

Clinical Assessment of a Daily Wear Monthly Replacement Soft Silicone Hydrogel Contact Lens

The purpose of this study is to assess the clinical performance of an investigational contact lens over 30 days of daily wear.

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Key information

Conditions

Myopia Eye Diseases Refractive Errors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alcon Investigative Site, Maitland, Florida, 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 60 days (30 days for each product).

Who can participate

Healthy volunteers accepted: No

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

Key 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;
  • Current wearer of spherical weekly/monthly soft contact lenses in both eyes with at least 3 months wearing time of 5 days per week and 10 hours per day;
  • Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

  • Current or prior Biofinity contact lens wearer in the past 3 months;
  • Monovision contact lens wearer;
  • Other protocol-defined exclusion criteria may apply.

Treatment and study plan

Lehfilcon A contact lenses

Device

Investigational silicone hydrogel contact lenses

Other names: LID018869

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. Mean Distance Visual Acuity (logMAR) With Study Lenses

    Time frame: Day 1, Day 30 after 6-8 hours of wear, each product

    Visual acuity (VA) was collected for each eye individually with study lenses in place at a distance of 4 meters using a letter chart. VA was measured in logarithm minimum angle of resolution (logMAR). On Day 30, VA was assessed after 6-8 hours of wear. A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with a lower logMAR value indicating better visual acuity. No formal hypothesis testing was planned.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jul 20, 2020
Registry last updated
Oct 26, 2021

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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