Back to resultsComparison of Two Daily Disposable Lenses
Primary Purpose
Refractive Ametropia, Myopia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
DACP FreshTech contact lenses
DACP contact lenses
Sponsored by
About this trial
This is an interventional treatment trial for Refractive Ametropia focused on measuring eye strain, eye fatigue
Eligibility Criteria
Inclusion Criteria:
- At least 3 months of soft contact lens wearing experience;
- Wears habitual lenses at least 5 days per week and at least 8 hours per day;
- Uses digital devices (computer, tablet, and/or smart phone) for an average of 4 hours per day;
- Experiences eye fatigue at least once per week attributable to digital device use with habitual lenses;
- Is willing to NOT use rewetting/lubricating drops during the period of study product exposure;
- Other protocol-specified inclusion criteria may apply.
Exclusion Criteria:
- Routinely sleeps in contact lenses;
- Known pregnancy at time of enrollment;
- Binocular vision issues or issues of eye alignment;
- Any eye infection, inflammation, disease or abnormality that contraindicates contact lens wear;
- Use of medications as specified in the protocol;
- Ocular surgery within the past 12 months;
- Other protocol-specified exclusion criteria may apply.
Sites / Locations
- Alcon Investigative Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
DACP FreshTech, then DACP
DACP, then DACP FreshTech
Arm Description
DACP FreshTech contact lenses worn first, followed by DACP contact lenses, as randomized. Each product was worn in both eyes for approximately 8 hours per day for 1 week with a new pair of lenses worn each day.
DACP contact lenses worn first, followed by DACP FreshTech contact lenses, as randomized.. Each product was worn in both eyes for approximately 8 hours per day, for 1 week with a new pair of lenses worn each day.
Outcomes
Primary Outcome Measures
Mean Distance Visual Acuity (VA) With Study Lenses
VA was assessed at a distance of 4 meters using a letter chart and was measured in logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with a lower logMAR value indicating better visual acuity.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04013789
Brief Title
Comparison of Two Daily Disposable Lenses
Official Title
Comparison of Two Daily Disposable Lenses
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
August 27, 2019 (Actual)
Primary Completion Date
November 22, 2019 (Actual)
Study Completion Date
November 22, 2019 (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
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study was to compare the clinical performance of the new DAILIES® AquaComfort PLUS® FreshTech (DACP FreshTech) contact lenses to an already marketed daily disposable contact lens, DAILIES® AquaComfort PLUS® (DACP).
Detailed Description
Subjects attended 4 scheduled visits for an expected duration of participation of 3 weeks.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractive Ametropia, Myopia
Keywords
eye strain, eye fatigue
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
79 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DACP FreshTech, then DACP
Arm Type
Other
Arm Description
DACP FreshTech contact lenses worn first, followed by DACP contact lenses, as randomized. Each product was worn in both eyes for approximately 8 hours per day for 1 week with a new pair of lenses worn each day.
Arm Title
DACP, then DACP FreshTech
Arm Type
Other
Arm Description
DACP contact lenses worn first, followed by DACP FreshTech contact lenses, as randomized.. Each product was worn in both eyes for approximately 8 hours per day, for 1 week with a new pair of lenses worn each day.
Intervention Type
Device
Intervention Name(s)
DACP FreshTech contact lenses
Other Intervention Name(s)
DAILIES® AquaComfort PLUS® FreshTech
Intervention Description
Nelfilcon A soft contact lenses with a modified lens design
Intervention Type
Device
Intervention Name(s)
DACP contact lenses
Other Intervention Name(s)
DAILIES® AquaComfort PLUS®
Intervention Description
Nelfilcon A soft contact lenses
Primary Outcome Measure Information:
Title
Mean Distance Visual Acuity (VA) With Study Lenses
Description
VA was assessed at a distance of 4 meters using a letter chart and was measured in logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with a lower logMAR value indicating better visual acuity.
Time Frame
Week 1, each product
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
At least 3 months of soft contact lens wearing experience;
Wears habitual lenses at least 5 days per week and at least 8 hours per day;
Uses digital devices (computer, tablet, and/or smart phone) for an average of 4 hours per day;
Experiences eye fatigue at least once per week attributable to digital device use with habitual lenses;
Is willing to NOT use rewetting/lubricating drops during the period of study product exposure;
Other protocol-specified inclusion criteria may apply.
Exclusion Criteria:
Routinely sleeps in contact lenses;
Known pregnancy at time of enrollment;
Binocular vision issues or issues of eye alignment;
Any eye infection, inflammation, disease or abnormality that contraindicates contact lens wear;
Use of medications as specified in the protocol;
Ocular surgery within the past 12 months;
Other protocol-specified exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sr. Clinical Project Lead
Organizational Affiliation
Alcon Research
Official's Role
Study Director
Facility Information:
Facility Name
Alcon Investigative Site
City
Bloomington
State/Province
Indiana
ZIP/Postal Code
47405
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparison of Two Daily Disposable Lenses
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