NCT05702541

Brief Summary

The purpose of this clinical trial is to assess the clinical performance of LID223194 Multifocal (MF) contact lenses and commercially available Air Optix plus HydraGlyde (AOHG) MF contact lenses. Eligible subjects will wear each study lens type in a cross-over fashion as randomized for approximately 2 days.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 4, 2023

Completed
20 days until next milestone

Study Start

First participant enrolled

January 24, 2023

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 27, 2023

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 21, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 21, 2023

Completed
1 year until next milestone

Results Posted

Study results publicly available

February 28, 2024

Completed
Last Updated

March 26, 2024

Status Verified

February 1, 2024

Enrollment Period

28 days

First QC Date

January 4, 2023

Results QC Date

February 2, 2024

Last Update Submit

February 27, 2024

Conditions

Presbyopia

Keywords

Contact lenses

Outcome Measures

Primary Outcomes (1)

  • Mean Binocular Visual Acuity (VA) With Study Lenses at 4 Meters (logMAR)

    VA was assessed binocularly (both eyes together) using a letter chart and measured in logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with lower logMAR values indicating better visual acuity. No hypothesis testing was pre-specified for this endpoint.

    Day 2 of each study lens type worn during the corresponding crossover period

Study Arms (2)

LID223194 MF, then AOHG MF

OTHER

Lehfilcon A multifocal contact lenses worn first, followed by lotrafilcon B multifocal contact lenses, as randomized. Each product will be worn in both eyes for 2 days in a daily wear modality. CLEAR CARE will be used for daily cleaning and disinfection.

Device: Lehfilcon A multifocal contact lensesDevice: Lotrafilcon B multifocal contact lensesDevice: Hydrogen peroxide-based cleaning and disinfection system

AOHG MF, then LID223194 MF

OTHER

Lotrafilcon B multifocal contact lenses worn first, followed by lehfilcon A multifocal contact lenses, as randomized. Each product will be worn in both eyes for 2 days in a daily wear modality. CLEAR CARE will be used for daily cleaning and disinfection.

Device: Lehfilcon A multifocal contact lensesDevice: Lotrafilcon B multifocal contact lensesDevice: Hydrogen peroxide-based cleaning and disinfection system

Interventions

Lehfilcon A multifocal contact lensesDEVICE

Silicone hydrogel multifocal contact lenses

Also known as: LID223194 MF contact lenses
AOHG MF, then LID223194 MFLID223194 MF, then AOHG MF
Lotrafilcon B multifocal contact lensesDEVICE

Silicone hydrogel multifocal contact lenses

Also known as: AOHG MF contact lenses
AOHG MF, then LID223194 MFLID223194 MF, then AOHG MF
Hydrogen peroxide-based cleaning and disinfection systemDEVICE

Commercially available cleaning and disinfection system for silicone hydrogel contact lenses

Also known as: CLEAR CARE
AOHG MF, then LID223194 MFLID223194 MF, then AOHG MF

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Able to understand and sign an consent form (ICF) that has been approved by an Institutional Review Board (IRB);
  • Willing to stop wearing habitual contact lenses for the duration of study participation;
  • Currently wearing multifocal soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months;

You may not qualify if:

  • Any eye infection, inflammation, or abnormality or disease (including systemic) that contraindicates contact lens wear, as determined by the investigator;
  • Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the investigator;
  • History of refractive surgery, or plan to have refractive surgery during the study;
  • Current or history of dry eye in either eye that would preclude contact lens wear, in the opinion of the investigator;
  • Monovision contact lens wear;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Creek Research Clinic

Johns Creek, Georgia, 30097, United States

Location

MeSH Terms

Conditions

Presbyopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Results Point of Contact

Title
Sr. Clinical Project Lead, Vision Care
Organization
Alcon Research, LLC
alcon.medinfo@alcon.com
1-888-451-3937

Study Officials

  • 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
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2023

First Posted

January 27, 2023

Study Start

January 24, 2023

Primary Completion

February 21, 2023

Study Completion

February 21, 2023

Last Updated

March 26, 2024

Results First Posted

February 28, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)