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Clinical Performance Evaluation of Two Frequent Replacement Silicone Hydrogel Multifocal Contact Lenses

Primary Purpose

Presbyopia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lehfilcon A multifocal contact lenses
Lotrafilcon B multifocal contact lenses
CLEAR CARE®
Sponsored by
Alcon Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Presbyopia focused on measuring Contact lenses, Multifocal

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

  • Able to understand and sign an informed consent form that has been approved by an Institutional Review Board.
  • Willing and able to attend all study visits as required by the protocol.
  • Willing to stop wearing habitual contact lenses for the duration of the study.
  • Currently wearing daily disposable and biweekly/monthly replacement multifocal soft contact lenses in both eyes at least 5 days per week and at least 8 hours per day for at least 3 months. AOHG MF wearers may be included.
  • Other protocol-specified inclusion criteria may apply.

Key Exclusion Criteria:

  • Any eye infection, inflammation, 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 planning to have refractive surgery during the study.
  • Current or history of pathologically dry eye.
  • Currently pregnant or lactating.
  • Other protocol-specified exclusion criteria may apply.

Sites / Locations

  • Kindred Optics at Maitland Vision
  • Vision Health Institute
  • Kannarr Eye Care LLC
  • The Eye Doctors, Inc.
  • Complete Eye Care of Medina
  • ProCare Vision Centers, Inc.
  • West Bay Eye Associates
  • Optometry Group, PLLC

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

LID210464, then AOHG MF

AOHG MF, then LID210464

Arm Description

Lehfilcon A multifocal contact lenses (LID210464) worn in Period 1, with lotrafilcon B multifocal contact lenses (AOHG MF) worn in Period 2, as randomized. Each study lens type will be worn bilaterally (in both eyes) for 30 days. CLEAR CARE® will be used for nightly contact lens cleaning and disinfecting.

Lotrafilcon B multifocal contact lenses (AOHG MF) worn in Period 1, with lehfilcon A multifocal contact lenses (LID210464) worn in Period 2, as randomized. Each study lens type will be worn bilaterally (in both eyes) for 30 days. CLEAR CARE® will be used for nightly contact lens cleaning and disinfecting.

Outcomes

Primary Outcome Measures

Least Squares Mean Binocular High Contrast/High Illumination Visual Acuity at Distance With Study Lenses
Visual acuity (VA) was assessed with study lenses in place under high contrast, high illumination. VA was collected for both eyes together using logarithmic of the Minimum Angle of Resolution (logMAR) charts. A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity (normal visual acuity), with a negative value denoting better than 20/20 visual acuity.

Secondary Outcome Measures

Full Information

First Posted
April 14, 2022
Last Updated
August 23, 2023
Sponsor
Alcon Research
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1. Study Identification

Unique Protocol Identification Number
NCT05338333
Brief Title
Clinical Performance Evaluation of Two Frequent Replacement Silicone Hydrogel Multifocal Contact Lenses
Official Title
Clinical Performance Evaluation of Two Frequent Replacement Silicone Hydrogel Multifocal Contact Lenses
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
May 27, 2022 (Actual)
Primary Completion Date
September 1, 2022 (Actual)
Study Completion Date
September 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary objective of this study is to demonstrate noninferiority in visual acuity at distance when wearing the test contact lenses (LID210464) compared to the control contact lenses (AOHG MF) after 30 days of wear.
Detailed Description
Subjects will be expected to attend 4 office visits and will be dispensed study contact lenses (test lenses and control lenses) for a 30-day duration of bilateral wear for each study lens type (total of approximately 60 days of contact lens wear).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Presbyopia
Keywords
Contact lenses, Multifocal

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
101 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LID210464, then AOHG MF
Arm Type
Other
Arm Description
Lehfilcon A multifocal contact lenses (LID210464) worn in Period 1, with lotrafilcon B multifocal contact lenses (AOHG MF) worn in Period 2, as randomized. Each study lens type will be worn bilaterally (in both eyes) for 30 days. CLEAR CARE® will be used for nightly contact lens cleaning and disinfecting.
Arm Title
AOHG MF, then LID210464
Arm Type
Other
Arm Description
Lotrafilcon B multifocal contact lenses (AOHG MF) worn in Period 1, with lehfilcon A multifocal contact lenses (LID210464) worn in Period 2, as randomized. Each study lens type will be worn bilaterally (in both eyes) for 30 days. CLEAR CARE® will be used for nightly contact lens cleaning and disinfecting.
Intervention Type
Device
Intervention Name(s)
Lehfilcon A multifocal contact lenses
Other Intervention Name(s)
LID210464
Intervention Description
Investigational frequent replacement soft contact lens indicated for the optical correction of presbyopia
Intervention Type
Device
Intervention Name(s)
Lotrafilcon B multifocal contact lenses
Other Intervention Name(s)
AOHG MF, AIR OPTIX® plus HydraGlyde® Multifocal (AOHG MF) contact lenses
Intervention Description
Commercially available frequent replacement soft contact lens indicated for the optical correction of presbyopia
Intervention Type
Device
Intervention Name(s)
CLEAR CARE®
Intervention Description
Hydrogen peroxide-based contact lens cleaning and disinfecting solution
Primary Outcome Measure Information:
Title
Least Squares Mean Binocular High Contrast/High Illumination Visual Acuity at Distance With Study Lenses
Description
Visual acuity (VA) was assessed with study lenses in place under high contrast, high illumination. VA was collected for both eyes together using logarithmic of the Minimum Angle of Resolution (logMAR) charts. A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity (normal visual acuity), with a negative value denoting better than 20/20 visual acuity.
Time Frame
Day 30, each wear period. A wear period was approximately 30 days.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Able to understand and sign an informed consent form that has been approved by an Institutional Review Board. Willing and able to attend all study visits as required by the protocol. Willing to stop wearing habitual contact lenses for the duration of the study. Currently wearing daily disposable and biweekly/monthly replacement multifocal soft contact lenses in both eyes at least 5 days per week and at least 8 hours per day for at least 3 months. AOHG MF wearers may be included. Other protocol-specified inclusion criteria may apply. Key Exclusion Criteria: Any eye infection, inflammation, 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 planning to have refractive surgery during the study. Current or history of pathologically dry eye. Currently pregnant or lactating. Other protocol-specified exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trial Lead, Vision Care
Organizational Affiliation
Alcon Research, LLC
Official's Role
Study Director
Facility Information:
Facility Name
Kindred Optics at Maitland Vision
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
Vision Health Institute
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Kannarr Eye Care LLC
City
Pittsburg
State/Province
Kansas
ZIP/Postal Code
66762
Country
United States
Facility Name
The Eye Doctors, Inc.
City
Eden Prairie
State/Province
Minnesota
ZIP/Postal Code
55344
Country
United States
Facility Name
Complete Eye Care of Medina
City
Medina
State/Province
Minnesota
ZIP/Postal Code
55340
Country
United States
Facility Name
ProCare Vision Centers, Inc.
City
Granville
State/Province
Ohio
ZIP/Postal Code
43023
Country
United States
Facility Name
West Bay Eye Associates
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02888
Country
United States
Facility Name
Optometry Group, PLLC
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38111
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Clinical Performance Evaluation of Two Frequent Replacement Silicone Hydrogel Multifocal Contact Lenses

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