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OpenTrials
Completed

NCT Number: NCT05886907

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

The purpose of this clinical trial is to assess on-eye performance and overall fit of an investigational multifocal toric contact lens to aid in confirmation of the study lens design.

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Key information

Conditions

Refractive Errors Astigmatism Eye Diseases Presbyopia

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 attend 3 study visits with a planned 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:

  • Requires ADD (additional power for near vision);
  • Currently wears multifocal soft contact lenses in both eyes during the past 3 months;
  • Manifest cylinder power between -0.75 diopter (D) and -1.00 D;
  • Best Corrected Visual Acuity (BCVA) of logMAR 0.10 (Snellen 20/25) or better in each eye.
  • Other protocol-specified inclusion criteria may apply.

Key Exclusion Criteria:

  • Any anterior segment 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;
  • Current or history of pathologically dry eye in either eye that, in the opinion of the Investigator, would preclude contact lens wear;
  • Monovision contact lens wear.
  • Other protocol-specified exclusion criteria may apply.

Treatment and study plan

Lehfilcon A multifocal toric contact lenses

Device

Investigational silicone hydrogel contact lenses

Other names: LID223188

Samfilcon A multifocal toric contact lenses

Device

Commercially available silicone hydrogel contact lenses

Other names: Ultra MFT, Bausch + Lomb Ultra® Multifocal for Astigmatism

CLEAR CARE

Device

Hydrogen peroxide based contact lens cleaning and disinfecting solution

Other names: CLEAR CARE® Cleaning and Disinfecting Solution

Primary outcomes

  1. Mean Distance Visual Acuity (VA) With Study Lenses

    Time frame: Day 2, each wear period. A wear period was approximately 2 days.

    Visual Acuity (VA) was assessed binocularly (both eyes together) with study lenses in place at a distance of 4 meters using letter charts. VA was recorded in logarithm minimum angle of resolution (logMAR), where 0.0 logMAR equates to 20/20 Snellen (normal distance eyesight). A lower number indicates better visual acuity. No hypothesis testing is 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
Jun 2, 2023
Registry last updated
Jul 31, 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.

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