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.

Study Overview

• Status: Completed
• Conditions: Refractive Errors; Presbyopia; Astigmatism
• Intervention / Treatment: Device: CLEAR CARE; Device: Lehfilcon A multifocal toric contact lenses; Device: Samfilcon A multifocal toric contact lenses

Detailed Description

Subjects will attend 3 study visits with a planned individual duration of participation of up to 10 days.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Johns Creek, Georgia, United States, 30097
      • Johns Creek Research Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: LID223188, then Ultra MFT; Lehfilcon A multifocal toric contact lenses worn first, with samfilcon A multifocal toric contact lenses worn second. Each product will be worn bilaterally (in both eyes) during waking hours for approximately 2 days. CLEAR CARE will be used for daily contact lens cleaning and disinfection.	Device: CLEAR CARE; Hydrogen peroxide based contact lens cleaning and disinfecting solution; Other Names: CLEAR CARE® Cleaning and Disinfecting Solution; Device: Lehfilcon A multifocal toric contact lenses; Investigational silicone hydrogel contact lenses; Other Names: LID223188; Device: Samfilcon A multifocal toric contact lenses; Commercially available silicone hydrogel contact lenses; Other Names: Ultra MFT; Bausch + Lomb Ultra® Multifocal for Astigmatism
Other: Ultra MFT, then LID223188; Samfilcon A multifocal toric contact lenses worn first, with lehfilcon A multifocal toric contact lenses worn second. Each product will be worn bilaterally (in both eyes) during waking hours for approximately 2 days. CLEAR CARE will be used for daily contact lens cleaning and disinfection.	Device: CLEAR CARE; Hydrogen peroxide based contact lens cleaning and disinfecting solution; Other Names: CLEAR CARE® Cleaning and Disinfecting Solution; Device: Lehfilcon A multifocal toric contact lenses; Investigational silicone hydrogel contact lenses; Other Names: LID223188; Device: Samfilcon A multifocal toric contact lenses; Commercially available silicone hydrogel contact lenses; Other Names: Ultra MFT; Bausch + Lomb Ultra® Multifocal for Astigmatism

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Distance Visual Acuity (VA) With Study Lenses	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.	Day 2, each wear period. A wear period was approximately 2 days.

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: Clinical Trial Lead, CRD Vision Care, Alcon Research, LLC

Study record dates

Study Major Dates

• Study Start (Actual): June 14, 2023
• Primary Completion (Actual): July 17, 2023
• Study Completion (Actual): July 17, 2023

Study Registration Dates

• First Submitted: May 24, 2023
• First Submitted That Met QC Criteria: May 24, 2023
• First Posted (Actual): June 2, 2023

Study Record Updates

• Last Update Posted (Actual): July 31, 2024
• Last Update Submitted That Met QC Criteria: July 8, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Contact Lenses
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Presbyopia; Astigmatism
• Other Study ID Numbers: CLR624-M103

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No