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OpenTrials
Completed

NCT Number: NCT04055519

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

The purpose of this study is to obtain on-eye performance data to inform contact lens product development.

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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

Alcon Investigative Site, Maitland, Florida, United States

Loading trial locations.

About this study

Subjects are expected to attend 5 scheduled visits. The expected duration of subject participation in the study is approximately 60 days, with approximately 30 days (± 2 days) per product.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Sign Informed Consent document.
  • Successful wear of spherical weekly/monthly soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months.
  • Possess spectacles that provide a corrected visual acuity of 20/40 or better in both eyes.
  • Other protocol-specified inclusion criteria may apply.

Exclusion criteria

  • Any eye condition or disease or use of medication that contraindicates contact lens wear.
  • Eye surgery, irregular cornea, eye injury as specified in the protocol.
  • Routinely sleeps in contact lenses at least 1 night per week over the last 3 months prior to enrollment.
  • Any use of topical ocular medications, artificial tear or rewetting drops that would require instillation during contact lens wear.
  • Habitually wears Biofinity contact lenses.
  • Other protocol-specified exclusion criteria may apply.

Treatment and study plan

Lehfilcon A contact lenses

Device

Investigational silicone hydrogel contact lenses

Other names: LID017569

Comfilcon A contact lenses

Device

Commercially available silicone hydrogel contact lenses

Other names: Biofinity®

Multi-purpose disinfection solution

Device

Solution for cleaning, disinfecting, and reconditioning silicone hydrogel contact lenses

Other names: OPTI-FREE® RepleniSH®

Primary outcomes

  1. Distance VA (logMAR) With Study Lenses

    Time frame: Day 30 after a minimum of 6 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). 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
2019
Primary completion
2019
Study completion
2019
First posted
Aug 13, 2019
Registry last updated
May 13, 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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