Back to resultsDD T2 Daily Disposable Registration Trial
Primary Purpose
Myopia, Refractive Errors
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
verofilcon A contact lenses
delefilcon A contact lenses
Sponsored by
About this trial
This is an interventional treatment trial for Myopia focused on measuring soft contact lenses, vision, eyesight
Eligibility 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.
Sites / Locations
- Alcon Investigative Site
- Alcon Investigative Site
- Alcon Investigative Site
- Alcon Investigative Site
- Alcon Investigative Site
- Alcon Investigative Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
DD T2
DT 1
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Monocular Visual Acuity (VA) With Contact Lenses at Each Visit (Snellen)
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03305770
Brief Title
DD T2 Daily Disposable Registration Trial
Official Title
DD T2 Daily Disposable Registration Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
October 12, 2017 (Actual)
Primary Completion Date
February 21, 2018 (Actual)
Study Completion Date
February 21, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research
4. Oversight
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
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia, Refractive Errors
Keywords
soft contact lenses, vision, eyesight
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
107 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DD T2
Arm Type
Experimental
Arm Description
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.
Arm Title
DT 1
Arm Type
Active Comparator
Arm Description
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 Type
Device
Intervention Name(s)
verofilcon A contact lenses
Other Intervention Name(s)
DD T2
Intervention Description
Daily disposable soft contact lenses
Intervention Type
Device
Intervention Name(s)
delefilcon A contact lenses
Other Intervention Name(s)
DAILIES TOTAL1®, DT1
Intervention Description
Daily disposable soft contact lenses
Primary Outcome Measure Information:
Title
Monocular Visual Acuity (VA) With Contact Lenses at Each Visit (Snellen)
Description
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.
Time Frame
Dispense, Week 1, Week 2, Month 1, Month 2, Month 3
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alcon, a Novartis Division
Organizational Affiliation
Alcon, a Novartis Division
Official's Role
Study Director
Facility Information:
Facility Name
Alcon Investigative Site
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Alcon Investigative Site
City
Longwood
State/Province
Florida
ZIP/Postal Code
32779
Country
United States
Facility Name
Alcon Investigative Site
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
Alcon Investigative Site
City
Bloomington
State/Province
Illinois
ZIP/Postal Code
61701
Country
United States
Facility Name
Alcon Investigative Site
City
Brentwood
State/Province
Tennessee
ZIP/Postal Code
37027
Country
United States
Facility Name
Alcon Investigative Site
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38111
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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DD T2 Daily Disposable Registration Trial
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