Skip to main content
OpenTrials
Completed

NCT Number: NCT05702541

Assessing the Clinical Performance of Two Frequent Replacement Silicone Hydrogel Multifocal Contact Lenses

The purpose of this clinical trial is to assess the clinical performance of LID223194 Multifocal (MF) contact lenses and commercially available Air Optix plus HydraGlyde (AOHG) MF contact lenses. Eligible subjects will wear each study lens type in a cross-over fashion as randomized for approximately 2 days.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Presbyopia Eye Diseases Refractive Errors

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Creek Research Clinic

Johns Creek, Georgia, 30097, United States

About this study

Subjects will be expected to attend 3 scheduled visits for an individual duration of participation of up to 10 days.

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 consent form (ICF) that has been approved by an Institutional Review Board (IRB);
  • Willing to stop wearing habitual contact lenses for the duration of study participation;
  • Currently wearing multifocal soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months;
  • Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

  • Any eye infection, inflammation, or abnormality or disease (including systemic) that contraindicates contact lens wear, as determined by the investigator;
  • Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the investigator;
  • History of refractive surgery, or plan to have refractive surgery during the study;
  • Current or history of dry eye in either eye that would preclude contact lens wear, in the opinion of the investigator;
  • Monovision contact lens wear;
  • Other protocol-defined exclusion criteria may apply.

Treatment and study plan

Lehfilcon A multifocal contact lenses

Device

Silicone hydrogel multifocal contact lenses

Other names: LID223194 MF contact lenses

Lotrafilcon B multifocal contact lenses

Device

Silicone hydrogel multifocal contact lenses

Other names: AOHG MF contact lenses

Hydrogen peroxide-based cleaning and disinfection system

Device

Commercially available cleaning and disinfection system for silicone hydrogel contact lenses

Other names: CLEAR CARE

Primary outcomes

  1. Mean Binocular Visual Acuity (VA) With Study Lenses at 4 Meters (logMAR)

    Time frame: Day 2 of each study lens type worn during the corresponding crossover period

    VA was assessed binocularly (both eyes together) using a letter chart and measured in logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with lower logMAR values indicating better visual acuity. No hypothesis testing was pre-specified 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
Jan 27, 2023
Registry last updated
Mar 26, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.