Clinical Performance of Two Frequent Replacement Silicone Hydrogel Multifocal Contact Lenses

NCT06469242 | Completed Results FDA Device

• 1 other identifier: CLM234-C001
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 8

Brief Summary

The purpose of this study is to evaluate the on-eye multifocal clinical performance of investigational LID233309 contact lenses and Oasys multifocal (MF) contact lenses in a daily wear dispensing trial.

Conditions

Presbyopia

Keywords

Multifocal; Myopia; Hyperopia

Outcome Measures

Primary Outcomes (1)

• Mean Binocular Visual Acuity at Distance (4 Meters) at Week 1

  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). No hypothesis testing was pre-specified for this endpoint.

  Week 1 (Day 7 -0/+1 days) of each wear period. A wear period was 14 days (-0/+2 days) according to randomization assignment.

Study Arms (2)

LID233309, then Oasys MF

OTHER

Serafilcon A multifocal contact lenses worn in Period 1, followed by senofilcon A multifocal contact lenses worn in Period 2, as randomized. The study lenses will be worn in a daily wear mode in both eyes (bilaterally) during waking hours for at least 10 hours per day. Each wear period is 14 days (-0/+2). CLEAR CARE will be used for daily cleaning and disinfection.

Device: Serafilcon A multifocal contact lenses; Device: Senofilcon A multifocal contact lenses; Device: CLEAR CARE® Cleaning & Disinfecting Solution

Oasys MF, then LID233309

OTHER

Senofilcon A multifocal contact lenses worn in Period 1, followed by serafilcon A multifocal contact lenses worn in Period 2, as randomized. The study lenses will be worn in a daily wear mode in both eyes (bilaterally) during waking hours for at least 10 hours per day. Each wear period is 14 days (-0/+2). CLEAR CARE will be used for daily cleaning and disinfection.

Device: Serafilcon A multifocal contact lenses; Device: Senofilcon A multifocal contact lenses; Device: CLEAR CARE® Cleaning & Disinfecting Solution

Interventions

Serafilcon A multifocal contact lenses DEVICE

Investigational multifocal soft contact lenses

Also known as: LID233309

LID233309, then Oasys MF; Oasys MF, then LID233309

Senofilcon A multifocal contact lenses DEVICE

Commercially available multifocal soft contact lenses

Also known as: ACUVUE® OASYS MULTIFOCAL with PUPIL OPTIMIZED DESIGN, Oasys MF

LID233309, then Oasys MF; Oasys MF, then LID233309

CLEAR CARE® Cleaning & Disinfecting Solution DEVICE

Hydrogen peroxide-based contact lens cleaning and disinfection system

Also known as: CLEAR CARE

LID233309, then Oasys MF; Oasys MF, then LID233309

Eligibility Criteria

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

You may qualify if:

• Current wearer of biweekly/monthly replacement multifocal soft contact lenses in both eyes for a minimum of 5 days per week and 10 hours per day during the past 6 months.
• Manifest cylinder equal to or less than 0.75 diopter (D) in each eye.
• Able to wear contact lenses within the available power range with a near ADD of +0.75 D to +2.50 D in each eye.

You may not qualify if:

• Currently pregnant or lactating.
• History of amblyopia, strabismus, or binocular vision abnormalities.
• Habitual Oasys MF contact lens wearers or daily disposable contact lens wearers.
• Monovision contact lens wearers and wearers of contact lens in one eye only.

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (8)

Kurata Eyecare Center

Los Angeles, California, 90013, United States

Location

Elsa Pao, OD

Oakland, California, 94607, United States

Location

Drs. Giedd, P.A.

Maitland, Florida, 32751, United States

Location

Vision Health Institute

Orlando, Florida, 32803, United States

Location

Wesley Optometric Consulting

Medina, Minnesota, 55340, 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

MeSH Terms

Conditions

Presbyopia; 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 17, 2024
• First Posted: June 21, 2024
• Study Start: July 18, 2024
• Primary Completion: October 8, 2024
• Study Completion: October 8, 2024
• Last Updated: October 9, 2025
• Results First Posted: October 9, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)