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OpenTrials
Completed

NCT Number: NCT05338333

Clinical Performance Evaluation of Two Frequent Replacement Silicone Hydrogel Multifocal Contact Lenses

The primary objective of this study is to demonstrate noninferiority in visual acuity at distance when wearing the test contact lenses (LID210464) compared to the control contact lenses (AOHG MF) after 30 days of wear.

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kindred Optics at Maitland Vision, Maitland, Florida, United States

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About this study

Subjects will be expected to attend 4 office visits and will be dispensed study contact lenses (test lenses and control lenses) for a 30-day duration of bilateral wear for each study lens type (total of approximately 60 days of contact lens wear).

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 informed consent form that has been approved by an Institutional Review Board.
  • Willing and able to attend all study visits as required by the protocol.
  • Willing to stop wearing habitual contact lenses for the duration of the study.
  • Currently wearing daily disposable and biweekly/monthly replacement multifocal soft contact lenses in both eyes at least 5 days per week and at least 8 hours per day for at least 3 months. AOHG MF wearers may be included.
  • Other protocol-specified inclusion criteria may apply.

Key Exclusion Criteria:

  • Any eye infection, inflammation, 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 planning to have refractive surgery during the study.
  • Current or history of pathologically dry eye.
  • Currently pregnant or lactating.
  • Other protocol-specified exclusion criteria may apply.

Treatment and study plan

Lehfilcon A multifocal contact lenses

Device

Investigational frequent replacement soft contact lens indicated for the optical correction of presbyopia

Other names: LID210464

Lotrafilcon B multifocal contact lenses

Device

Commercially available frequent replacement soft contact lens indicated for the optical correction of presbyopia

Other names: AOHG MF, AIR OPTIX® plus HydraGlyde® Multifocal (AOHG MF) contact lenses

CLEAR CARE®

Device

Hydrogen peroxide-based contact lens cleaning and disinfecting solution

Primary outcomes

  1. Least Squares Mean Binocular High Contrast/High Illumination Visual Acuity at Distance With Study Lenses

    Time frame: Day 30, each wear period. A wear period was approximately 30 days.

    Visual acuity (VA) was assessed with study lenses in place under high contrast, high illumination. VA was collected for both eyes together 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
2022
Primary completion
2022
Study completion
2022
First posted
Apr 21, 2022
Registry last updated
Sep 13, 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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