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

NCT ID: NCT06461455

Last Updated: 2025-12-24

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

95 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-26

Study Completion Date

2024-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Presbyopia Astigmatism

Keywords

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Myopia Hyperopia Multifocal Toric

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type OTHER

Lehfilcon A multifocal for astigmatism contact lenses

Intervention Type DEVICE

Investigational multifocal contact lenses for astigmatism

Samfilcon A multifocal for astigmatism contact lenses

Intervention Type DEVICE

Commercially available multifocal contact lenses for astigmatism

CLEAR CARE® Cleaning & Disinfecting Solution

Intervention Type DEVICE

Hydrogen peroxide-based contact lens cleaning and disinfection system

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.

Group Type OTHER

Samfilcon A multifocal for astigmatism contact lenses

Intervention Type DEVICE

Commercially available multifocal contact lenses for astigmatism

Lehfilcon A multifocal for astigmatism contact lenses

Intervention Type DEVICE

Investigational multifocal contact lenses for astigmatism

CLEAR CARE® Cleaning & Disinfecting Solution

Intervention Type DEVICE

Hydrogen peroxide-based contact lens cleaning and disinfection system

Interventions

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Lehfilcon A multifocal for astigmatism contact lenses

Investigational multifocal contact lenses for astigmatism

Intervention Type DEVICE

Samfilcon A multifocal for astigmatism contact lenses

Commercially available multifocal contact lenses for astigmatism

Intervention Type DEVICE

CLEAR CARE® Cleaning & Disinfecting Solution

Hydrogen peroxide-based contact lens cleaning and disinfection system

Intervention Type DEVICE

Lehfilcon A multifocal for astigmatism contact lenses

Investigational multifocal contact lenses for astigmatism

Intervention Type DEVICE

CLEAR CARE® Cleaning & Disinfecting Solution

Hydrogen peroxide-based contact lens cleaning and disinfection system

Intervention Type DEVICE

Other Intervention Names

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ULTRA® Multifocal for Astigmatism CLEAR CARE CLEAR CARE

Eligibility Criteria

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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;

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;
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alcon Research

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sr. Clinical Trial Lead, Vision Care

Role: STUDY_DIRECTOR

Alcon Research, LLC

Locations

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Dr.Elsa Pao, O.D

Oakland, California, United States

Site Status

Pacific Rims Optometry

San Francisco, California, United States

Site Status

Drs. Giedd, P.A.

Maitland, Florida, United States

Site Status

Vision Health Institute

Orlando, Florida, United States

Site Status

Kannarr Eye Care LLC

Pittsburg, Kansas, United States

Site Status

Wesley Optometric Consulting

Medina, Minnesota, United States

Site Status

Oculus Research, Inc.

Garner, North Carolina, United States

Site Status

ProCare Vision Centers, Inc.

Granville, Ohio, United States

Site Status

Insight Research Clinic LLC

Powell, Ohio, United States

Site Status

Optometry Group, PLLC

Memphis, Tennessee, United States

Site Status

Dawn M. Rakich, OD

San Antonio, Texas, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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CLR624-C001

Identifier Type: -

Identifier Source: org_study_id