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DD T2 Daily Disposable Registration Trial

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ClinicalTrials.gov Identifier: NCT03305770
Recruitment Status : Completed
First Posted : October 10, 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 October 5, 2017
First Posted Date  ICMJE October 10, 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 October 12, 2017
Actual Primary Completion Date February 21, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 30, 2019)
Monocular Visual Acuity (VA) With Contact Lenses at Each Visit (Snellen) [ Time Frame: Dispense, Week 1, Week 2, Month 1, Month 2, Month 3 ]
VA was assessed for each eye individually using a Snellen chart at a distance of 4 meters. A 20/20 Snellen acuity is considered normal distance eyesight. No formal hypotheses were formulated; hence no inferential testing was performed.
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT03305770 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 DD T2 Daily Disposable Registration Trial
Official Title  ICMJE DD T2 Daily Disposable Registration Trial
Brief Summary The purpose of this study is to evaluate the performance of the investigational verofilcon A contact lens compared to the commercially available delefilcon A contact lens, by assessing visual acuity as the primary variable.
Detailed Description Enrolled participants will be randomized (2:1) to receive either verofilcon A (test) contact lenses or delefilcon A (control) contact lenses for wear in both eyes and attend 7 office visits: Baseline, Dispense, 1-week follow-up, 2-week follow-up, 1-month follow-up, 2-month follow-up and 3-month follow-up/Exit.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Myopia
  • Refractive Errors
Intervention  ICMJE
  • Device: verofilcon A contact lenses
    Daily disposable soft contact lenses
    Other Name: DD T2
  • Device: delefilcon A contact lenses
    Daily disposable soft contact lenses
    Other Names:
    • DAILIES TOTAL1®
    • DT1
Study Arms  ICMJE
  • Experimental: DD T2
    Verofilcon A contact lenses worn in both eyes for 3 months in a daily wear, daily disposable modality. A new pair of study lenses will be inserted each day and discarded at the end of the day.
    Intervention: Device: verofilcon A contact lenses
  • Active Comparator: DT 1
    Delefilcon A contact lenses worn in both eyes for 3 months in a daily wear, daily disposable modality. A new pair of study lenses will be inserted each day and discarded at the end of the day.
    Intervention: Device: delefilcon 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)
107
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE February 21, 2018
Actual Primary Completion Date February 21, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Successful wear of spherical soft contact lenses for distance correction in both eyes during the past 3 months for a minimum of 5 days per week and 8 hours per day.
  • Best corrected VA 20/25 or better in each eye.
  • Other protocol-specified inclusion criteria may apply.

Exclusion Criteria

  • Any current or prior wear experience with DT1 lenses.
  • Wearing habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment.
  • Other protocol-specified 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 NCT03305770
Other Study ID Numbers  ICMJE CLE383-C005
Has Data Monitoring Committee Not Provided
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
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: Alcon, a Novartis Division Alcon, a Novartis Division
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