Clinical Performance Evaluation of Two Frequent Replacement Silicone Hydrogel Multifocal Contact Lenses
1 other identifier
interventional
101
1 country
8
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2022
Shorter than P25 for not_applicable
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 14, 2022
CompletedFirst Posted
Study publicly available on registry
April 21, 2022
CompletedStudy Start
First participant enrolled
May 27, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2022
CompletedResults Posted
Study results publicly available
September 13, 2023
CompletedSeptember 13, 2023
August 1, 2023
3 months
April 14, 2022
August 23, 2023
August 23, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Day 30, each wear period. A wear period was approximately 30 days.
Study Arms (2)
LID210464, then AOHG MF
OTHERLehfilcon 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.
AOHG MF, then LID210464
OTHERLotrafilcon 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.
Interventions
Investigational frequent replacement soft contact lens indicated for the optical correction of presbyopia
Commercially available frequent replacement soft contact lens indicated for the optical correction of presbyopia
Hydrogen peroxide-based contact lens cleaning and disinfecting solution
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alcon Researchlead
Study Sites (8)
Kindred Optics at Maitland Vision
Maitland, Florida, 32751, United States
Vision Health Institute
Orlando, Florida, 32803, United States
Kannarr Eye Care LLC
Pittsburg, Kansas, 66762, United States
The Eye Doctors, Inc.
Eden Prairie, Minnesota, 55344, United States
Complete Eye Care of Medina
Medina, Minnesota, 55340, United States
ProCare Vision Centers, Inc.
Granville, Ohio, 43023, United States
West Bay Eye Associates
Warwick, Rhode Island, 02888, United States
Optometry Group, PLLC
Memphis, Tennessee, 38111, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Sr. Clinical Project Lead, Vision Care
- Organization
- Alcon Research, LLC
Study Officials
- STUDY DIRECTOR
Clinical Trial Lead, Vision Care
Alcon Research, LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 14, 2022
First Posted
April 21, 2022
Study Start
May 27, 2022
Primary Completion
September 1, 2022
Study Completion
September 1, 2022
Last Updated
September 13, 2023
Results First Posted
September 13, 2023
Record last verified: 2023-08
Data Sharing
- IPD Sharing
- Will not share