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Assessing the Clinical Performance 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
Hydrogen peroxide-based cleaning and disinfection system
Sponsored by
Alcon Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Presbyopia

Eligibility Criteria

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

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.

Sites / Locations

  • Alcon Study Site 07898

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

LID# 2223194 MF, then AOHG MF

AOHG MF, then LID# 223194 MF

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Binocular Visual Acuity (VA) with Study Lenses at 4 meters (logMAR)
VA will be 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.

Secondary Outcome Measures

Full Information

First Posted
January 4, 2023
Last Updated
June 5, 2023
Sponsor
Alcon Research
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1. Study Identification

Unique Protocol Identification Number
NCT05702541
Brief Title
Assessing the Clinical Performance of Two Frequent Replacement Silicone Hydrogel Multifocal Contact Lenses
Official Title
Assessing the Clinical Performance of Two Frequent Replacement Silicone Hydrogel Multifocal Contact Lenses
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
January 24, 2023 (Actual)
Primary Completion Date
February 21, 2023 (Actual)
Study Completion Date
February 21, 2023 (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
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief Summary
The purpose of this clinical trial is to assess the clinical performance of LID# 223194 Multifocal (MF) contact lens and a commercially available Air Optix plus HydraGlyde (AOHG) MF contact lens. Eligible subjects will wear each study lens type in a cross-over fashion as randomized for approximately 2 days.
Detailed Description
Subjects will be expected to attend 3 scheduled visits.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Presbyopia

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LID# 2223194 MF, then AOHG MF
Arm Type
Other
Arm Description
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.
Arm Title
AOHG MF, then LID# 223194 MF
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Lehfilcon A multifocal contact lenses
Other Intervention Name(s)
LID# 223194 MF contact lenses
Intervention Description
Silicone hydrogel multifocal contact lenses
Intervention Type
Device
Intervention Name(s)
Lotrafilcon B multifocal contact lenses
Other Intervention Name(s)
AOHG MF contact lenses
Intervention Description
Silicone hydrogel multifocal contact lenses
Intervention Type
Device
Intervention Name(s)
Hydrogen peroxide-based cleaning and disinfection system
Other Intervention Name(s)
CLEAR CARE
Intervention Description
Commercially available cleaning and disinfection system for silicone hydrogel contact lenses
Primary Outcome Measure Information:
Title
Binocular Visual Acuity (VA) with Study Lenses at 4 meters (logMAR)
Description
VA will be 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.
Time Frame
Day 2, each study lens type

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 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.
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
Alcon Study Site 07898
City
Johns Creek
State/Province
Georgia
ZIP/Postal Code
30097
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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