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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

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.

Condition or disease Intervention/treatment Phase
Myopia Refractive Errors Device: verofilcon A contact lenses Device: delefilcon A contact lenses Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 107 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: DD T2 Daily Disposable Registration Trial
Actual Study Start Date : October 12, 2017
Actual Primary Completion Date : February 21, 2018
Actual Study Completion Date : February 21, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

Arm Intervention/treatment
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.
Device: verofilcon A contact lenses
Daily disposable soft contact lenses
Other Name: DD T2

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.
Device: delefilcon A contact lenses
Daily disposable soft contact lenses
Other Names:
  • DAILIES TOTAL1®
  • DT1




Primary Outcome Measures :
  1. 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.



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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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03305770


Locations
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United States, California
Alcon Investigative Site
San Diego, California, United States, 92123
United States, Florida
Alcon Investigative Site
Longwood, Florida, United States, 32779
Alcon Investigative Site
Maitland, Florida, United States, 32751
United States, Illinois
Alcon Investigative Site
Bloomington, Illinois, United States, 61701
United States, Tennessee
Alcon Investigative Site
Brentwood, Tennessee, United States, 37027
Alcon Investigative Site
Memphis, Tennessee, United States, 38111
Sponsors and Collaborators
Alcon Research
Investigators
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Study Director: Alcon, a Novartis Division Alcon, a Novartis Division
  Study Documents (Full-Text)

Documents provided by Alcon Research:
Study Protocol  [PDF] August 24, 2017
Statistical Analysis Plan  [PDF] September 22, 2017


Additional Information:
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Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT03305770     History of Changes
Other Study ID Numbers: CLE383-C005
First Posted: October 10, 2017    Key Record Dates
Results First Posted: February 22, 2019
Last Update Posted: February 22, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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

Keywords provided by Alcon Research:
soft contact lenses
vision
eyesight

Additional relevant MeSH terms:
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Refractive Errors
Eye Diseases