Back to resultsClinical Comparison of 4 Daily Disposable Soft Contact Lenses
Primary Purpose
Refractive Error
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
verofilcon A contact lenses
senofilcon A contact lenses
stenfilcon A contact lenses
etafilcon A contact lenses
Sponsored by
About this trial
This is an interventional treatment trial for Refractive Error focused on measuring Contact lenses, Myopia, Near-sighted, Daily disposable
Eligibility Criteria
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
Sites / Locations
- Alcon Investigative Site
- Alcon Investigative Site
- Alcon Investigative Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Other
Other
Arm Label
DD T2/Oasys 1-Day
DD T2/MyDay
DD T2/Moist
Arm Description
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
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
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
Outcomes
Primary Outcome Measures
Overall Quality of Vision
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03349632
Brief Title
Clinical Comparison of 4 Daily Disposable Soft Contact Lenses
Official Title
Clinical Comparison of 4 Daily Disposable Soft Contact Lenses
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
January 10, 2018 (Actual)
Primary Completion Date
February 16, 2018 (Actual)
Study Completion Date
February 16, 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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractive Error
Keywords
Contact lenses, Myopia, Near-sighted, Daily disposable
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
68 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DD T2/Oasys 1-Day
Arm Type
Other
Arm Description
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
Arm Title
DD T2/MyDay
Arm Type
Other
Arm Description
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
Arm Title
DD T2/Moist
Arm Type
Other
Arm Description
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
Intervention Type
Device
Intervention Name(s)
verofilcon A contact lenses
Other Intervention Name(s)
DDT2
Intervention Description
Investigational spherical silicone hydrogel contact lenses for daily disposable wear
Intervention Type
Device
Intervention Name(s)
senofilcon A contact lenses
Other Intervention Name(s)
ACUVUE OASYS® 1-Day with HydraLuxe™ Technology, Oasys 1-Day
Intervention Description
Commercially available spherical silicone hydrogel contact lenses for daily disposable wear
Intervention Type
Device
Intervention Name(s)
stenfilcon A contact lenses
Other Intervention Name(s)
MyDay®, MyDay
Intervention Description
Commercially available spherical silicone hydrogel contact lenses for daily disposable wear
Intervention Type
Device
Intervention Name(s)
etafilcon A contact lenses
Other Intervention Name(s)
1-Day ACUVUE® MOIST, Moist
Intervention Description
Commercially available spherical silicone hydrogel contact lenses for daily disposable wear
Primary Outcome Measure Information:
Title
Overall Quality of Vision
Description
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.
Time Frame
Day 8, each product
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Alcon Investigative Site
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
Alcon Investigative Site
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32503
Country
United States
Facility Name
Alcon Investigative Site
City
Johns Creek
State/Province
Georgia
ZIP/Postal Code
30097
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Comparison of 4 Daily Disposable Soft Contact Lenses
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