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Clinical Comparison of 4 Daily Disposable Soft Contact Lenses

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ClinicalTrials.gov Identifier: NCT03349632
Recruitment Status : Completed
First Posted : November 21, 2017
Results First Posted : February 22, 2019
Last Update Posted : February 22, 2019
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Tracking Information
First Submitted Date  ICMJE November 17, 2017
First Posted Date  ICMJE November 21, 2017
Results First Submitted Date  ICMJE January 30, 2019
Results First Posted Date  ICMJE February 22, 2019
Last Update Posted Date February 22, 2019
Actual Study Start Date  ICMJE January 10, 2018
Actual Primary Completion Date February 16, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 30, 2019)
Overall Quality of Vision [ Time Frame: Day 8, each product ]
Overall quality of vision was collected binocularly and rated on a 10-point scale with 1 = poor to 10 = excellent. Subjects were asked "Thinking back over the last week, please rate our study lenses. Rate eyes together." No formal hypotheses was conducted; hence no inferential testing was performed.
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT03349632 on ClinicalTrials.gov Archive Site
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 4 Daily Disposable Soft Contact Lenses
Official Title  ICMJE Clinical Comparison of 4 Daily Disposable Soft Contact Lenses
Brief Summary The purpose of this study is to obtain on-eye performance data to inform contact lens product development and to further evaluate product performance in the intended population.
Detailed Description The expected duration of subject participation in the study is approximately 20 days with 3 scheduled visits. Each subject will evaluate the test contact lenses compared to 1 of 3 commercially available contact lenses.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Refractive Error
Intervention  ICMJE
  • Device: verofilcon A contact lenses
    Investigational spherical silicone hydrogel contact lenses for daily disposable wear
    Other Name: DDT2
  • Device: senofilcon A contact lenses
    Commercially available spherical silicone hydrogel contact lenses for daily disposable wear
    Other Names:
    • ACUVUE OASYS® 1-Day with HydraLuxe™ Technology
    • Oasys 1-Day
  • Device: stenfilcon A contact lenses
    Commercially available spherical silicone hydrogel contact lenses for daily disposable wear
    Other Names:
    • MyDay®
    • MyDay
  • Device: etafilcon A contact lenses
    Commercially available spherical silicone hydrogel contact lenses for daily disposable wear
    Other Names:
    • 1-Day ACUVUE® MOIST
    • Moist
Study Arms  ICMJE
  • DD T2/Oasys 1-Day
    Verofilcon A contact lenses and senofilcon A contact lenses worn in both eyes, each product, for 1 week on a daily wear basis, as randomized
    Interventions:
    • Device: verofilcon A contact lenses
    • Device: senofilcon A contact lenses
  • DD T2/MyDay
    Verofilcon A contact lenses and stenfilcon A contact lenses worn in both eyes, each product, for 1 week on a daily disposable basis, as randomized
    Interventions:
    • Device: verofilcon A contact lenses
    • Device: stenfilcon A contact lenses
  • DD T2/Moist
    Verofilcon A contact lenses and etafilcon A contact lenses worn in both eyes, each product, for 1 week on a daily disposable basis, as randomized
    Interventions:
    • Device: verofilcon A contact lenses
    • Device: etafilcon 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: January 3, 2019)
68
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE February 16, 2018
Actual Primary Completion Date February 16, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Able to understand and must sign an approved Informed Consent Form
  • Successfully wears daily disposable spherical soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months
  • Best Corrected Visual Acuity of 20/25 Snellen or better in each eye
  • Willing to stop wearing habitual contact lenses for the duration of study participation
  • Other protocol-defined inclusion criteria may apply

Exclusion Criteria:

  • Any eye condition, surgery, disease, or use of medication that contraindicates contact lens wear, as determined by the Investigator.
  • Routinely sleeps in habitual contact lenses
  • Currently wears Oasys 1-Day, MyDay, or Moist 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 NCT03349632
Other Study ID Numbers  ICMJE CLE383-C004
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
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
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 Not Provided
PRS Account Alcon Research
Verification Date January 2019

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