Back to resultsClinical Assessment of a Daily Disposable Soft Silicone Hydrogel Contact Lens
Primary Purpose
Refractive Errors
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Delefilcon A contact lenses
Sponsored by
About this trial
This is an interventional treatment trial for Refractive Errors focused on measuring Contact Lenses
Eligibility Criteria
Key Inclusion Criteria: Current wearer of commercial spherical soft contact lenses in both eyes with at least 3 months of wearing experience, with a minimum wearing time of 5 days per week and 10 hours per day; Manifest cylinder less than or equal to 0.75 diopter (D) in each eye; Best corrected distance visual acuity better than or equal to 20/25 (Snellen) in each eye. Key Exclusion Criteria: Current or prior habitual DAILIES TOTAL1 soft contact lens wear in the past 3 months prior to consent; Monovision contact lens wear; 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.
Sites / Locations
- Tallahassee Eye CenterRecruiting
- The Eye Doctors, Inc.Recruiting
- Oculus Research, Inc.Recruiting
- ProCare Vision CenterRecruiting
- Wyomissing Optometric CenterRecruiting
- Optometry Group, PLLCRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
DAILIES TOTAL1
Arm Description
Delefilcon A contact lenses worn in both eyes for the typical number of hours the subject wears his/her habitual contact lenses. The lenses will be worn in a daily disposable manner.
Outcomes
Primary Outcome Measures
Distance VA with study lenses at Week 1
Visual acuity (VA) will be measured with study lenses on eye using letter charts. VA will be recorded in Snellen where 20/20 represents normal distance eyesight.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06044948
Brief Title
Clinical Assessment of a Daily Disposable Soft Silicone Hydrogel Contact Lens
Official Title
Clinical Assessment of a Daily Disposable Soft Silicone Hydrogel Contact Lens
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 13, 2023 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)
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 assess the clinical performance of DAILIES TOTAL1® spherical soft contact lenses over approximately 1 week of daily wear.
Detailed Description
Subjects will be expected to attend 2 visits (Visit 1 Screen/Baseline/ Dispense; and Visit 2 Week 1 Follow-up/ Exit). The total duration of a subject's participation in the study as well as exposure to the contact lenses will be approximately 1 week (6-8 days of contact lens wear).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractive Errors
Keywords
Contact Lenses
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
In this single arm study, the subject will be masked to the lens type.
Allocation
N/A
Enrollment
96 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
DAILIES TOTAL1
Arm Type
Experimental
Arm Description
Delefilcon A contact lenses worn in both eyes for the typical number of hours the subject wears his/her habitual contact lenses. The lenses will be worn in a daily disposable manner.
Intervention Type
Device
Intervention Name(s)
Delefilcon A contact lenses
Other Intervention Name(s)
DAILIES TOTAL1
Intervention Description
Daily disposable, silicone hydrogel spherical contact lenses
Primary Outcome Measure Information:
Title
Distance VA with study lenses at Week 1
Description
Visual acuity (VA) will be measured with study lenses on eye using letter charts. VA will be recorded in Snellen where 20/20 represents normal distance eyesight.
Time Frame
Week 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Key Inclusion Criteria:
Current wearer of commercial spherical soft contact lenses in both eyes with at least 3 months of wearing experience, with a minimum wearing time of 5 days per week and 10 hours per day;
Manifest cylinder less than or equal to 0.75 diopter (D) in each eye;
Best corrected distance visual acuity better than or equal to 20/25 (Snellen) in each eye.
Key Exclusion Criteria:
Current or prior habitual DAILIES TOTAL1 soft contact lens wear in the past 3 months prior to consent;
Monovision contact lens wear;
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alcon Call Center
Phone
1-888-451-3937
Email
alcon.medinfo@alcon.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trial Lead, CRD Vision Care
Organizational Affiliation
Alcon Research, LLC
Official's Role
Study Director
Facility Information:
Facility Name
Tallahassee Eye Center
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Individual Site Status
Recruiting
Facility Name
The Eye Doctors, Inc.
City
Eden Prairie
State/Province
Minnesota
ZIP/Postal Code
55344
Country
United States
Individual Site Status
Recruiting
Facility Name
Oculus Research, Inc.
City
Garner
State/Province
North Carolina
ZIP/Postal Code
27529
Country
United States
Individual Site Status
Recruiting
Facility Name
ProCare Vision Center
City
Granville
State/Province
Ohio
ZIP/Postal Code
43023
Country
United States
Individual Site Status
Recruiting
Facility Name
Wyomissing Optometric Center
City
Wyomissing
State/Province
Pennsylvania
ZIP/Postal Code
19610
Country
United States
Individual Site Status
Recruiting
Facility Name
Optometry Group, PLLC
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38111
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Assessment of a Daily Disposable Soft Silicone Hydrogel Contact Lens
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