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

December 22, 2025 updated by: Alcon Research
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Subjects will wear two different contact lens study products in a cross-over fashion. Each study product type will be worn for approximately 30 days. A washout period of 2-4 days will occur prior to the first wear period and between the two wear periods. Subjects will be expected to attend 5 office visits. The total duration of study participation is approximately 66 days.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
95

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • California
      • Oakland, California, United States, 94607
        • Dr.Elsa Pao, O.D
      • San Francisco, California, United States, 94127
        • Pacific Rims Optometry
    • Florida
      • Maitland, Florida, United States, 32751
        • Drs. Giedd, P.A.
      • Orlando, Florida, United States, 32803
        • Vision Health Institute
    • Kansas
      • Pittsburg, Kansas, United States, 66762
        • Kannarr Eye Care LLC
    • Minnesota
      • Medina, Minnesota, United States, 55340
        • Wesley Optometric Consulting
    • North Carolina
      • Garner, North Carolina, United States, 27529
        • Oculus Research, Inc.
    • Ohio
      • Granville, Ohio, United States, 43023
        • ProCare Vision Centers, Inc.
      • Powell, Ohio, United States, 43065
        • Insight Research Clinic LLC
    • Tennessee
      • Memphis, Tennessee, United States, 38111
        • Optometry Group, PLLC
    • Texas
      • San Antonio, Texas, United States, 78213
        • Dawn M. Rakich, OD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  • 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;
  • Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

  • 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;
  • Other protocol-defined exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: LID230451, then ULTRA MFfA
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
Investigational multifocal contact lenses for astigmatism
Device: Samfilcon A multifocal for astigmatism contact lenses
Commercially available multifocal contact lenses for astigmatism
Other Names:
  • ULTRA® Multifocal for Astigmatism
Device: CLEAR CARE® Cleaning & Disinfecting Solution
Hydrogen peroxide-based contact lens cleaning and disinfection system
Other Names:
  • CLEAR CARE
Other: ULTRA MFfA, then LID230451
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: Lehfilcon A multifocal for astigmatism contact lenses
Investigational multifocal contact lenses for astigmatism
Device: Samfilcon A multifocal for astigmatism contact lenses
Commercially available multifocal contact lenses for astigmatism
Other Names:
  • ULTRA® Multifocal for Astigmatism
Device: CLEAR CARE® Cleaning & Disinfecting Solution
Hydrogen peroxide-based contact lens cleaning and disinfection system
Other Names:
  • CLEAR CARE

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mean Binocular Visual Acuity at Distance (4 Meters) at Day 30 With Study Lenses
Time Frame: Day 30 (-2/+1) of each wear period. A wear period was 30 days (-2/+1) according to randomization assignment.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Alcon Research

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Sr. Clinical Trial Lead, Vision Care, Alcon Research, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 26, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 12, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 12, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 17, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 24, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 22, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CLR624-C001

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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