Back to resultsPerformance Assessment of a Modified Daily Disposable Contact Lens
Primary Purpose
Refractive Errors, Myopia, Hyperopia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Modified delefilcon A contact lenses
Delefilcon A contact lenses
Sponsored by
About this trial
This is an interventional treatment trial for Refractive Errors focused on measuring Contact lens, Vision correction, Visual acuity
Eligibility Criteria
Inclusion Criteria:
- Able to understand and sign an approved Informed Consent form;
- Current wearer of commercial DAILIES TOTAL1 Contact Lenses in both eyes;
- Other protocol-specified inclusion criteria may apply.
Exclusion Criteria:
- Any eye condition that contraindicates contact lens wear, as determined by the Investigator;
- Any eye surgery that contraindicates contact lens wear, as determined by the Investigator;
- Wears habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week)
- Monocular (only one eye with functional vision);
- Other protocol-specified exclusion criteria may apply.
Sites / Locations
- 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
Other
Other
Arm Label
MDACL, then DACL
DACL, then MDACL
Arm Description
Modified delefilcon A contact lenses (MDACL) worn first, followed by delefilcon A contact lenses (DACL), as randomized. Each product worn bilaterally (in both eyes) for approximately 1 week in a daily disposable modality.
DACL worn first, followed by MDACL, as randomized. Each product worn bilaterally for approximately 1 week in a daily disposable modality.
Outcomes
Primary Outcome Measures
High Contrast Distance Visual Acuity (logMAR)
Distance visual acuity (VA) testing was performed using letter charts. Each row of the chart contained 5 letters, with the letters on each row progressively smaller than the row above. The subject read the letters from larger to smaller. The test terminated when the subject either misidentified a majority of letters on 1 row or progressed to the smallest row of letters. Visual acuity scoring sheets were used to record the number of letters correctly read. LogMAR VA was calculated based on the total number of letters read incorrectly as follows: LogMAR Acuity = base reading + (0.02 x number of letters missed). A lower logMAR value indicates better VA.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03762668
Brief Title
Performance Assessment of a Modified Daily Disposable Contact Lens
Official Title
Performance Assessment of a Modified Daily Disposable Contact Lens
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
December 3, 2018 (Actual)
Primary Completion Date
January 7, 2019 (Actual)
Study Completion Date
January 7, 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
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 compare visual acuity between two daily disposable contact lenses.
Detailed Description
The expected duration of subject participation in the study is approximately 2 weeks, with 3 scheduled visits.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractive Errors, Myopia, Hyperopia
Keywords
Contact lens, Vision correction, Visual acuity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
62 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MDACL, then DACL
Arm Type
Other
Arm Description
Modified delefilcon A contact lenses (MDACL) worn first, followed by delefilcon A contact lenses (DACL), as randomized. Each product worn bilaterally (in both eyes) for approximately 1 week in a daily disposable modality.
Arm Title
DACL, then MDACL
Arm Type
Other
Arm Description
DACL worn first, followed by MDACL, as randomized. Each product worn bilaterally for approximately 1 week in a daily disposable modality.
Intervention Type
Device
Intervention Name(s)
Modified delefilcon A contact lenses
Other Intervention Name(s)
MDACL
Intervention Description
Spherical soft daily disposable contact lens
Intervention Type
Device
Intervention Name(s)
Delefilcon A contact lenses
Other Intervention Name(s)
DACL
Intervention Description
Spherical soft daily disposable contact lens
Primary Outcome Measure Information:
Title
High Contrast Distance Visual Acuity (logMAR)
Description
Distance visual acuity (VA) testing was performed using letter charts. Each row of the chart contained 5 letters, with the letters on each row progressively smaller than the row above. The subject read the letters from larger to smaller. The test terminated when the subject either misidentified a majority of letters on 1 row or progressed to the smallest row of letters. Visual acuity scoring sheets were used to record the number of letters correctly read. LogMAR VA was calculated based on the total number of letters read incorrectly as follows: LogMAR Acuity = base reading + (0.02 x number of letters missed). A lower logMAR value indicates better VA.
Time Frame
Day 1 Dispense, Day 7 Follow-Up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Able to understand and sign an approved Informed Consent form;
Current wearer of commercial DAILIES TOTAL1 Contact Lenses in both eyes;
Other protocol-specified inclusion criteria may apply.
Exclusion Criteria:
Any eye condition that contraindicates contact lens wear, as determined by the Investigator;
Any eye surgery that contraindicates contact lens wear, as determined by the Investigator;
Wears habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week)
Monocular (only one eye with functional vision);
Other protocol-specified exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sr. CDMA Project Lead, Vision Care
Organizational Affiliation
Alcon Research
Official's Role
Study Director
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
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Alcon Investigative Site
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33405
Country
United States
Facility Name
Alcon Investigative Site
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48105
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
Learn more about this trial
Performance Assessment of a Modified Daily Disposable Contact Lens
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