Clinical Evaluation of a Manufacturing Process for a Frequent Replacement Silicone Hydrogel Multifocal Contact Lens

NCT05765227 | Completed Results FDA Device

• 1 other identifier: CLN705-M103
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this clinical trial was to evaluate the clinical performance of a manufacturing process on a frequent replacement multifocal contact lens.

Conditions

Refractive Ametropia

Keywords

Presbyopia

Outcome Measures

Primary Outcomes (1)

• 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 prespecified for this endpoint.

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

Study Arms (2)

LID#224381, then AOHG MF

OTHER

Lehfilcon A multifocal contact lenses worn first, with lotrafilcon B multifocal contact lenses worn second in pre-determined order. Each study lens type will be worn bilaterally (in both eyes) for approximately 2 days. CLEAR CARE will be used for nightly cleaning and disinfection.

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

AOHG MF, then LID#224381

OTHER

Lotrafilcon B multifocal contact lenses worn first, with lehfilcon A multifocal contact lenses worn second in pre-determined order. Each study lens type will be worn bilaterally (in both eyes) for approximately 2 days. CLEAR CARE will be used for nightly cleaning and disinfection.

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

Interventions

Lehfilcon A multifocal contact lenses DEVICE

Investigational silicone hydrogel multifocal contact lenses

Also known as: LID#224381 MF contact lenses

AOHG MF, then LID#224381; LID#224381, then AOHG MF

Lotrafilcon B multifocal contact lenses DEVICE

Commercially available silicone hydrogel multifocal contact lenses

Also known as: AOHG MF contact lenses, AIR OPTIX® plus HydraGlyde ® multifocal contact lenses (AOHG MF)

AOHG MF, then LID#224381; LID#224381, then AOHG MF

Hydrogen peroxide-based cleaning and disinfection system DEVICE

Commercially available cleaning and disinfection system for silicone hydrogel contact lenses

Also known as: CLEAR CARE®

AOHG MF, then LID#224381; LID#224381, then AOHG MF

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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;

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (1)

Johns Creek Research Clinic

Johns Creek, Georgia, 30097, United States

Location

MeSH Terms

Conditions

Presbyopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye 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: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2023
• First Posted: March 13, 2023
• Study Start: March 8, 2023
• Primary Completion: March 30, 2023
• Study Completion: March 30, 2023
• Last Updated: April 16, 2024
• Results First Posted: April 16, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)