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出境医 / 临床实验 / Clinical Comparison of Two Daily Disposable Contact Lenses - Pilot Study 3

Clinical Comparison of Two Daily Disposable Contact Lenses - Pilot Study 3

Study Description
Brief Summary:
The purpose of this study is to evaluate the overall performance of 2 new daily disposable contact lenses.

Condition or disease Intervention/treatment Phase
Myopia Ametropia Device: Verofilcon A contact lenses Device: Kalifilcon A contact lenses Not Applicable

Detailed Description:
The expected duration of subject participation in the study is up to 24 days, with 3 scheduled visits.
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Subjects will receive treatment based upon the randomized treatment sequence assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Clinical Comparison of Two Daily Disposable Contact Lenses - Pilot Study 3
Actual Study Start Date : July 20, 2021
Actual Primary Completion Date : September 9, 2021
Actual Study Completion Date : September 9, 2021
Arms and Interventions
Arm Intervention/treatment
Precision1, then Infuse
Verofilcon A contact lenses worn first, with kalifilcon A contact lenses worn second, as randomized. Each product will be worn bilaterally (in both eyes) for 8 -0/+3 days in a daily disposable modality.
 Device: Verofilcon A contact lenses
Commercially available silicone hydrogel contact lenses for daily disposable wear
Other Name: PRECISION1™

Device: Kalifilcon A contact lenses
Commercially available silicone hydrogel contact lenses for daily disposable wear
Other Name: Bausch + Lomb INFUSE™
Infuse, then Precision1
Kalifilcon A contact lenses worn first, with verofilcon A contact lenses worn second, as randomized. Each product will be worn bilaterally (in both eyes) for 8 -0/+3 days in a daily disposable modality.
 Device: Verofilcon A contact lenses
Commercially available silicone hydrogel contact lenses for daily disposable wear
Other Name: PRECISION1™

Device: Kalifilcon A contact lenses
Commercially available silicone hydrogel contact lenses for daily disposable wear
Other Name: Bausch + Lomb INFUSE™
Outcome Measures
Primary Outcome Measures :
  1. Distance VA (logMAR) with study lenses [ Time Frame: Day 8 (-0/+3 days), each product ]
    Distance VA with study lenses will be collected in logarithm Minimum Angle of Resolution (logMAR) for each eye.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Able to understand and sign an Informed Consent Form that been approved by an Institutional Review Board.
  • Successful wear of spherical soft contact lenses in both eyes for a minimum of 5 days per week and 10 hours per day during the past 3 months.
  • Willing to wear study contact lenses for at least 16 hours prior to the follow up visits.
  • Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

  • Current/previous PRECISION1 or INFUSE contact lens wearer.
  • Any eye condition or use of medication that contraindicates contact lens wear, as determined by the investigator.
  • Routinely sleeps in contact lenses.
  • Other protocol-defined exclusion criteria may apply.
Contacts and Locations

Locations
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United States, Florida
Alcon Investigator 6565
Maitland, Florida, United States, 32751
Alcon Investigator 6355
Orlando, Florida, United States, 32803
United States, Minnesota
Alcon Investigator 6583
Eden Prairie, Minnesota, United States, 55344
United States, Ohio
Alcon Investigator 6313
Powell, Ohio, United States, 43065
Sponsors and Collaborators
Alcon Research
Investigators
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Study Director: Clinical Trial Lead, Vision Care Alcon Research, LLC
Tracking Information
First Submitted Date  ICMJE June 21, 2021
First Posted Date  ICMJE June 29, 2021
Last Update Posted Date September 21, 2021
Actual Study Start Date  ICMJE July 20, 2021
Actual Primary Completion Date September 9, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 21, 2021) 		Distance VA (logMAR) with study lenses [ Time Frame: Day 8 (-0/+3 days), each product ]
Distance VA with study lenses will be collected in logarithm Minimum Angle of Resolution (logMAR) for each eye.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Comparison of Two Daily Disposable Contact Lenses - Pilot Study 3
Official Title  ICMJE Clinical Comparison of Two Daily Disposable Contact Lenses - Pilot Study 3
Brief Summary The purpose of this study is to evaluate the overall performance of 2 new daily disposable contact lenses.
Detailed Description The expected duration of subject participation in the study is up to 24 days, with 3 scheduled visits.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
Subjects will receive treatment based upon the randomized treatment sequence assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Myopia
  • Ametropia
Intervention  ICMJE
  • Device: Verofilcon A contact lenses
    Commercially available silicone hydrogel contact lenses for daily disposable wear
    Other Name: PRECISION1™
  • Device: Kalifilcon A contact lenses
    Commercially available silicone hydrogel contact lenses for daily disposable wear
    Other Name: Bausch + Lomb INFUSE™
Study Arms  ICMJE
  • Precision1, then Infuse
    Verofilcon A contact lenses worn first, with kalifilcon A contact lenses worn second, as randomized. Each product will be worn bilaterally (in both eyes) for 8 -0/+3 days in a daily disposable modality.
    Interventions:
    • Device: Verofilcon A contact lenses
    • Device: Kalifilcon A contact lenses
  • Infuse, then Precision1
    Kalifilcon A contact lenses worn first, with verofilcon A contact lenses worn second, as randomized. Each product will be worn bilaterally (in both eyes) for 8 -0/+3 days in a daily disposable modality.
    Interventions:
    • Device: Verofilcon A contact lenses
    • Device: Kalifilcon A contact lenses
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 21, 2021) 		60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 9, 2021
Actual Primary Completion Date September 9, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria:

  • Able to understand and sign an Informed Consent Form that been approved by an Institutional Review Board.
  • Successful wear of spherical soft contact lenses in both eyes for a minimum of 5 days per week and 10 hours per day during the past 3 months.
  • Willing to wear study contact lenses for at least 16 hours prior to the follow up visits.
  • Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

  • Current/previous PRECISION1 or INFUSE contact lens wearer.
  • Any eye condition or use of medication that contraindicates contact lens wear, as determined by the investigator.
  • Routinely sleeps in contact lenses.
  • Other protocol-defined exclusion criteria may apply.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04942925
Other Study ID Numbers  ICMJE CLE383-E002
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Alcon Research
Study Sponsor  ICMJE Alcon Research
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trial Lead, Vision Care Alcon Research, LLC
PRS Account Alcon Research
Verification Date September 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP