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

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

Study Overview

• Status: Completed
• Conditions: Refractive Ametropia
• Intervention / Treatment: Device: Hydrogen peroxide-based cleaning and disinfection system; Device: Lotrafilcon B multifocal contact lenses; Device: Lehfilcon A multifocal contact lenses

Detailed Description

Subjects will be expected to attend 3 scheduled visits. Eligible subjects will wear each study lens type in a cross-over fashion for approximately 2 days.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Johns Creek, Georgia, United States, 30097
      • Johns Creek Research Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Key Inclusion Criteria:

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

Key Exclusion Criteria:

• 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;
• Other protocol-defined exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: LID#224381, then AOHG MF; 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: Hydrogen peroxide-based cleaning and disinfection system; Commercially available cleaning and disinfection system for silicone hydrogel contact lenses; Other Names: CLEAR CARE®; Device: Lotrafilcon B multifocal contact lenses; Commercially available silicone hydrogel multifocal contact lenses; Other Names: AOHG MF contact lenses; AIR OPTIX® plus HydraGlyde ® multifocal contact lenses (AOHG MF); Device: Lehfilcon A multifocal contact lenses; Investigational silicone hydrogel multifocal contact lenses; Other Names: LID#224381 MF contact lenses
Other: AOHG MF, then LID#224381; 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: Hydrogen peroxide-based cleaning and disinfection system; Commercially available cleaning and disinfection system for silicone hydrogel contact lenses; Other Names: CLEAR CARE®; Device: Lotrafilcon B multifocal contact lenses; Commercially available silicone hydrogel multifocal contact lenses; Other Names: AOHG MF contact lenses; AIR OPTIX® plus HydraGlyde ® multifocal contact lenses (AOHG MF); Device: Lehfilcon A multifocal contact lenses; Investigational silicone hydrogel multifocal contact lenses; Other Names: LID#224381 MF contact lenses

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: Clinical Trial Lead, Vision Care, Alcon Research, LLC

Study record dates

Study Major Dates

• Study Start (Actual): March 8, 2023
• Primary Completion (Actual): March 30, 2023
• Study Completion (Actual): March 30, 2023

Study Registration Dates

• First Submitted: March 1, 2023
• First Submitted That Met QC Criteria: March 1, 2023
• First Posted (Actual): March 13, 2023

Study Record Updates

• Last Update Posted (Actual): April 16, 2024
• Last Update Submitted That Met QC Criteria: March 19, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Presbyopia
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Anti-Infective Agents, Local; Anti-Infective Agents; Hydrogen Peroxide
• Other Study ID Numbers: CLN705-M103

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