Clinical Performance of Two Frequent Replacement Silicone Hydrogel Multifocal Contact Lenses

June 20, 2024 updated by: Alcon Research
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Subjects will be expected to attend 7 office visits for an individual duration of participation of 28 to 40 days.

Study Type

Interventional

Enrollment (Estimated)

96

Phase

  • 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 Locations

  • United States
    • California
      • Los Angeles, California, United States, 90013
        • Kurata Eyecare Center
      • Oakland, California, United States, 94607
        • Elsa Pao, OD
    • Florida
      • Maitland, Florida, United States, 32751
        • Drs. Giedd, P.A.
      • Orlando, Florida, United States, 32803
        • Vision Health Institute
    • Minnesota
      • Medina, Minnesota, United States, 55340
        • Wesley Optometric Consulting
    • 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

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

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

Key Exclusion Criteria:

  • 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.
  • 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
Intervention / Treatment
Other: LID233309, then Oasys MF
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 bilaterally (in both eyes) during waking hours for at least 10 hours per day, each wear period [14 days (-0/+2)]. Study lenses will be removed daily for cleaning and disinfection with CLEAR CARE.
Device: Serafilcon A multifocal contact lenses
Investigational multifocal soft contact lenses
Other Names:
  • LID233309
Device: Senofilcon A multifocal contact lenses
Commercially available multifocal soft contact lenses
Other Names:
  • ACUVUE® OASYS MULTIFOCAL with PUPIL OPTIMIZED DESIGN
  • Oasys MF
Device: CLEAR CARE® Cleaning & Disinfecting Solution
Hydrogen peroxide-based contact lens cleaning and disinfection system
Other Names:
  • CLEAR CARE
Other: Oasys MF, then LID233309
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 bilaterally (in both eyes) during waking hours for at least 10 hours per day, each wear period [14 days (-0/+2)]. Study lenses will be removed daily for cleaning and disinfection with CLEAR CARE.
Device: Serafilcon A multifocal contact lenses
Investigational multifocal soft contact lenses
Other Names:
  • LID233309
Device: Senofilcon A multifocal contact lenses
Commercially available multifocal soft contact lenses
Other Names:
  • ACUVUE® OASYS MULTIFOCAL with PUPIL OPTIMIZED DESIGN
  • Oasys MF
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

Outcome Measure
Measure Description
Time Frame
Binocular visual acuity at distance (4 meters) at Week 1
Time Frame: Week 1 (Day 7 -0/+1 days) of each wear period. A wear period is 14 days (-0/+2 days) according to randomization assignment.
Visual Acuity (VA) will be assessed at a distance of 4 meters for both eyes together under high contrast, high illumination lighting with study lenses in place. VA will be measured using letter charts and recorded in logarithm minimum angle of resolution (logMAR), with a logMAR value of 0 equating to 20/20 Snellen VA (normal distance eyesight) and lower logMAR values representing better eyesight.
Week 1 (Day 7 -0/+1 days) of each wear period. A wear period is 14 days (-0/+2 days) according to randomization assignment.

Collaborators and Investigators

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

Sponsor

Alcon Research

Investigators

  • 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 (Estimated)

July 1, 2024

Primary Completion (Estimated)

October 1, 2024

Study Completion (Estimated)

October 1, 2024

Study Registration Dates

First Submitted

June 17, 2024

First Submitted That Met QC Criteria

June 17, 2024

First Posted (Actual)

June 21, 2024

Study Record Updates

Last Update Posted (Actual)

June 24, 2024

Last Update Submitted That Met QC Criteria

June 20, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLM234-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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