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

NCT05886907 | Completed Results FDA Device

• 1 other identifier: CLR624-M103
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this clinical trial is to assess on-eye performance and overall fit of an investigational multifocal toric contact lens to aid in confirmation of the study lens design.

Conditions

Refractive Errors; Presbyopia; Astigmatism

Keywords

Contact Lenses

Outcome Measures

Primary Outcomes (1)

• Mean Distance Visual Acuity (VA) With Study Lenses

  Visual Acuity (VA) was assessed binocularly (both eyes together) with study lenses in place at a distance of 4 meters using letter charts. VA was recorded in logarithm minimum angle of resolution (logMAR), where 0.0 logMAR equates to 20/20 Snellen (normal distance eyesight). A lower number indicates better visual acuity. No hypothesis testing is pre-specified for this endpoint.

  Day 2, each wear period. A wear period was approximately 2 days.

Study Arms (2)

LID223188, then Ultra MFT

OTHER

Lehfilcon A multifocal toric contact lenses worn first, with samfilcon A multifocal toric contact lenses worn second. Each product will be worn bilaterally (in both eyes) during waking hours for approximately 2 days. CLEAR CARE will be used for daily contact lens cleaning and disinfection.

Device: Lehfilcon A multifocal toric contact lenses; Device: Samfilcon A multifocal toric contact lenses; Device: CLEAR CARE

Ultra MFT, then LID223188

OTHER

Samfilcon A multifocal toric contact lenses worn first, with lehfilcon A multifocal toric contact lenses worn second. Each product will be worn bilaterally (in both eyes) during waking hours for approximately 2 days. CLEAR CARE will be used for daily contact lens cleaning and disinfection.

Device: Lehfilcon A multifocal toric contact lenses; Device: Samfilcon A multifocal toric contact lenses; Device: CLEAR CARE

Interventions

Lehfilcon A multifocal toric contact lenses DEVICE

Investigational silicone hydrogel contact lenses

Also known as: LID223188

LID223188, then Ultra MFT; Ultra MFT, then LID223188

Samfilcon A multifocal toric contact lenses DEVICE

Commercially available silicone hydrogel contact lenses

Also known as: Ultra MFT, Bausch + Lomb Ultra® Multifocal for Astigmatism

LID223188, then Ultra MFT; Ultra MFT, then LID223188

CLEAR CARE DEVICE

Hydrogen peroxide based contact lens cleaning and disinfecting solution

Also known as: CLEAR CARE® Cleaning and Disinfecting Solution

LID223188, then Ultra MFT; Ultra MFT, then LID223188

Eligibility Criteria

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

You may qualify if:

• Requires ADD (additional power for near vision);
• Currently wears multifocal soft contact lenses in both eyes during the past 3 months;
• Manifest cylinder power between -0.75 diopter (D) and -1.00 D;
• Best Corrected Visual Acuity (BCVA) of logMAR 0.10 (Snellen 20/25) or better in each eye.

You may not qualify if:

• Any anterior segment 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;
• Current or history of pathologically dry eye in either eye that, in the opinion of the Investigator, would preclude contact lens wear;
• 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

Refractive Errors; Presbyopia; Astigmatism

Condition Hierarchy (Ancestors)

Eye Diseases

Results Point of Contact

• Title: Clinical Project Lead, Vision Care
• Organization: Alcon Research, LLC

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Clinical Trial Lead, CRD 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

Model Details: Subjects will wear the products (test and comparator) in a predetermined order.

Study Record Dates

• First Submitted: May 24, 2023
• First Posted: June 2, 2023
• Study Start: June 14, 2023
• Primary Completion: July 17, 2023
• Study Completion: July 17, 2023
• Last Updated: July 31, 2024
• Results First Posted: July 31, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)