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

NCT06461455 | Completed Results FDA Device

• 1 other identifier: CLR624-C001
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 11

Brief Summary

The purpose of this study is to evaluate on-eye clinical performance of the investigational contact lenses following 30 days of wear in the intended population.

Conditions

Presbyopia; Astigmatism

Keywords

Myopia; Hyperopia; Multifocal; Toric

Outcome Measures

Primary Outcomes (1)

• Mean Binocular Visual Acuity at Distance (4 Meters) at Day 30 With Study Lenses

  Visual Acuity (VA) was assessed at a distance of 4 meters with both eyes together (binocular) under high contrast, high illumination lighting with study lenses in place. VA was measured using letter charts and recorded in the logarithm of the minimum angle of resolution (LogMAR). A LogMAR value of 0 equates to 20/20 Snellen VA (normal distance eyesight), with negative LogMAR values representing better than 20/20 VA. The LogMAR VA scale ranges from -0.30 (20/10 Snellen) to 1.00 (20/200 Snellen).

  Day 30 (-2/+1) of each wear period. A wear period was 30 days (-2/+1) according to randomization assignment.

Study Arms (2)

LID230451, then ULTRA MFfA

OTHER

Lehfilcon A multifocal for astigmatism contact lenses worn in Period 1, followed by samfilcon A multifocal for astigmatism contact lenses worn in Period 2, as randomized. The study lenses will be worn bilaterally (in both eyes) during typical contact lens wearing hours for at least 8 hours per day during each wear period \[30 days (-2/+1)\]. Study lenses will be removed daily for cleaning and disinfection with CLEAR CARE.

Device: Lehfilcon A multifocal for astigmatism contact lenses; Device: Samfilcon A multifocal for astigmatism contact lenses; Device: CLEAR CARE® Cleaning & Disinfecting Solution

ULTRA MFfA, then LID230451

OTHER

Samfilcon A multifocal for astigmatism contact lenses worn in Period 1, followed by lehfilcon A multifocal for astigmatism contact lenses worn in Period 2, as randomized. The study lenses will be worn bilaterally (in both eyes) during typical contact lens wearing hours for at least 8 hours per day during each wear period \[30 days (-2/+1)\]. Study lenses will be removed daily for cleaning and disinfection with CLEAR CARE.

Device: Samfilcon A multifocal for astigmatism contact lenses; Device: Lehfilcon A multifocal for astigmatism contact lenses; Device: CLEAR CARE® Cleaning & Disinfecting Solution

Interventions

Samfilcon A multifocal for astigmatism contact lenses DEVICE

Commercially available multifocal contact lenses for astigmatism

Also known as: ULTRA® Multifocal for Astigmatism

LID230451, then ULTRA MFfA; ULTRA MFfA, then LID230451

CLEAR CARE® Cleaning & Disinfecting Solution DEVICE

Hydrogen peroxide-based contact lens cleaning and disinfection system

Also known as: CLEAR CARE

LID230451, then ULTRA MFfA

Lehfilcon A multifocal for astigmatism contact lenses DEVICE

Investigational multifocal contact lenses for astigmatism

LID230451, then ULTRA MFfA

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Habitual wearer of biweekly/monthly replacement soft multifocal or multifocal toric contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months;
• Manifest cylinder equal to or greater than 0.75 diopter (D) in each eye at Screening;
• Willing to not use readers while wearing study contact lenses for duration of the study;

You may not qualify if:

• Use of topical ocular medications and artificial tear or rewetting drops that would require instillation during contact lens wear;
• Wears habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment;
• Monovision contact lens wearers and wearers of contact lens in one eye only;

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (11)

Dr.Elsa Pao, O.D

Oakland, California, 94607, United States

Location

Pacific Rims Optometry

San Francisco, California, 94127, United States

Location

Drs. Giedd, P.A.

Maitland, Florida, 32751, United States

Location

Vision Health Institute

Orlando, Florida, 32803, United States

Location

Kannarr Eye Care LLC

Pittsburg, Kansas, 66762, United States

Location

Wesley Optometric Consulting

Medina, Minnesota, 55340, United States

Location

Oculus Research, Inc.

Garner, North Carolina, 27529, United States

Location

ProCare Vision Centers, Inc.

Granville, Ohio, 43023, United States

Location

Insight Research Clinic LLC

Powell, Ohio, 43065, United States

Location

Optometry Group, PLLC

Memphis, Tennessee, 38111, United States

Location

Dawn M. Rakich, OD

San Antonio, Texas, 78213, United States

Location

MeSH Terms

Conditions

Presbyopia; Astigmatism; Myopia; Hyperopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Sr. Principal, Clinical Project Management, Vision Care
• Organization: Alcon Research, LLC

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Sr. Clinical Trial Lead, Vision Care

  Alcon Research, LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2024
• First Posted: June 17, 2024
• Study Start: July 26, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: December 24, 2025
• Results First Posted: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (11)