Back to resultsTwo Daily Disposable Contact Lenses in Symptomatic Patients
Primary Purpose
Myopia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Delefilcon A contact lenses
Senofilcon A contact lenses
Sponsored by
About this trial
This is an interventional treatment trial for Myopia focused on measuring Symptomatic
Eligibility Criteria
Inclusion Criteria:
- Able to understand and must sign an IRB-approved informed consent form;
- Soft contact lens wearers in both eyes during the past 3 months;
- Best-corrected visual acuity (BCVA) 20/25 or better in each eye;
- Willing to wear study lenses at least 3 days per week and at least 8 hours per day;
- Willing to stop wearing habitual contact lenses for the duration of study participation.
Exclusion Criteria:
- Infection, inflammation, abnormality, condition, disease, surgery, or use of medications, as specified in the protocol;
- Intolerance, hypersensitivity, or allergy to any component of the study products;
- 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;
- Monocular (only one eye with functional vision).
Sites / Locations
- 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
TOTAL1
1-DAY
Arm Description
Delefilcon A contact lenses worn bilaterally (in both eyes) for 4 weeks in a daily disposable modality
Senofilcon A contact lenses worn bilaterally for 4 weeks in a daily disposable modality
Outcomes
Primary Outcome Measures
Monocular Corrected Distance Visual Acuity (VA)
Monocular (each eye) corrected (with spectacles or other visual corrective devices) VA was performed under dimmed room illumination using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart at distance. VA was reported in logMAR ("logarithm of the minimum angle of resolution"), with a lower logMAR indicating better visual acuity. No inferential hypotheses was planned for this endpoint.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03628599
Brief Title
Two Daily Disposable Contact Lenses in Symptomatic Patients
Official Title
Two Daily Disposable Contact Lenses in Symptomatic Patients
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
August 13, 2018 (Actual)
Primary Completion Date
September 25, 2018 (Actual)
Study Completion Date
September 25, 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 evaluate the performance of DAILIES TOTAL1® and ACUVUE OASYS® 1-DAY and with respect to visual acuity in a symptomatic study population of monthly or bi-weekly replacement lens wearers.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia
Keywords
Symptomatic
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
39 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TOTAL1
Arm Type
Experimental
Arm Description
Delefilcon A contact lenses worn bilaterally (in both eyes) for 4 weeks in a daily disposable modality
Arm Title
1-DAY
Arm Type
Active Comparator
Arm Description
Senofilcon A contact lenses worn bilaterally for 4 weeks in a daily disposable modality
Intervention Type
Device
Intervention Name(s)
Delefilcon A contact lenses
Other Intervention Name(s)
DAILIES TOTAL1® (DT1)
Intervention Description
Water Gradient silicon hydrogel daily disposable contact lenses
Intervention Type
Device
Intervention Name(s)
Senofilcon A contact lenses
Other Intervention Name(s)
ACUVUE OASYS® 1-DAY
Intervention Description
Silicon hydrogel daily disposable contact lenses with HydraLuxe™ Technology
Primary Outcome Measure Information:
Title
Monocular Corrected Distance Visual Acuity (VA)
Description
Monocular (each eye) corrected (with spectacles or other visual corrective devices) VA was performed under dimmed room illumination using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart at distance. VA was reported in logMAR ("logarithm of the minimum angle of resolution"), with a lower logMAR indicating better visual acuity. No inferential hypotheses was planned for this endpoint.
Time Frame
Week 4
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 IRB-approved informed consent form;
Soft contact lens wearers in both eyes during the past 3 months;
Best-corrected visual acuity (BCVA) 20/25 or better in each eye;
Willing to wear study lenses at least 3 days per week and at least 8 hours per day;
Willing to stop wearing habitual contact lenses for the duration of study participation.
Exclusion Criteria:
Infection, inflammation, abnormality, condition, disease, surgery, or use of medications, as specified in the protocol;
Intolerance, hypersensitivity, or allergy to any component of the study products;
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;
Monocular (only one eye with functional vision).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alcon Research
Organizational Affiliation
Alcon Research
Official's Role
Study Director
Facility Information:
Facility Name
Alcon Investigative Site
City
Bloomington
State/Province
Illinois
ZIP/Postal Code
61701
Country
United States
Facility Name
Alcon Investigative Site
City
Pittsburg
State/Province
Kansas
ZIP/Postal Code
66762
Country
United States
Facility Name
Alcon Investigative Site
City
Powell
State/Province
Ohio
ZIP/Postal Code
43065
Country
United States
Facility Name
Alcon Investigative Site
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02888
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Two Daily Disposable Contact Lenses in Symptomatic Patients
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