Back to resultsClinical Assessment of a Daily Wear Monthly Replacement Soft Silicone Hydrogel Contact Lens
Primary Purpose
Myopia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lehfilcon A contact lenses
Comfilcon A contact lenses
CLEAR CARE
Sponsored by
About this trial
This is an interventional treatment trial for Myopia focused on measuring Contact lenses
Eligibility Criteria
Key Inclusion Criteria:
- Able to understand and sign an approved Informed Consent form;
- Willing and able to attend all scheduled study visits as required by the protocol;
- Current wearer of spherical weekly/monthly soft contact lenses in both eyes with at least 3 months wearing time of 5 days per week and 10 hours per day;
- Other protocol-defined inclusion criteria may apply.
Key Exclusion Criteria:
- Current or prior Biofinity contact lens wearer in the past 3 months;
- Monovision contact lens wearer;
- Other protocol-defined 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
LID018869, then Biofinity
Biofinity, then LID018869
Arm Description
Lehfilcon A contact lenses worn first, followed by comfilcon A contact lenses, as randomized. Each product will be worn in both eyes during waking hours only for at least 5 days per week over a 30-day period. CLEAR CARE will be used for nightly cleaning and disinfection.
Comfilcon A contact lenses worn first, followed by lehfilcon A contact lenses, as randomized. Each product will be worn in both eyes during waking hours only for at least 5 days per week over a 30-day period. CLEAR CARE will be used for nightly cleaning and disinfection.
Outcomes
Primary Outcome Measures
Mean Distance Visual Acuity (logMAR) With Study Lenses
Visual acuity (VA) was collected for each eye individually with study lenses in place at a distance of 4 meters using a letter chart. VA was measured in logarithm minimum angle of resolution (logMAR). On Day 30, VA was assessed after 6-8 hours of wear. A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with a lower logMAR value indicating better visual acuity. No formal hypothesis testing was planned.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04476784
Brief Title
Clinical Assessment of a Daily Wear Monthly Replacement Soft Silicone Hydrogel Contact Lens
Official Title
Clinical Assessment of a Daily Wear Monthly Replacement Soft Silicone Hydrogel Contact Lens
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
August 17, 2020 (Actual)
Primary Completion Date
November 18, 2020 (Actual)
Study Completion Date
November 18, 2020 (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 assess the clinical performance of an investigational contact lens over 30 days of daily wear.
Detailed Description
Subjects will wear two products and be expected to attend 4 office visits. The individual duration of participation will be approximately 60 days (30 days for each product).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia
Keywords
Contact lenses
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LID018869, then Biofinity
Arm Type
Other
Arm Description
Lehfilcon A contact lenses worn first, followed by comfilcon A contact lenses, as randomized. Each product will be worn in both eyes during waking hours only for at least 5 days per week over a 30-day period. CLEAR CARE will be used for nightly cleaning and disinfection.
Arm Title
Biofinity, then LID018869
Arm Type
Other
Arm Description
Comfilcon A contact lenses worn first, followed by lehfilcon A contact lenses, as randomized. Each product will be worn in both eyes during waking hours only for at least 5 days per week over a 30-day period. CLEAR CARE will be used for nightly cleaning and disinfection.
Intervention Type
Device
Intervention Name(s)
Lehfilcon A contact lenses
Other Intervention Name(s)
LID018869
Intervention Description
Investigational silicone hydrogel contact lenses
Intervention Type
Device
Intervention Name(s)
Comfilcon A contact lenses
Other Intervention Name(s)
CooperVision® BIOFINITY®, Biofinity
Intervention Description
Commercially available silicone hydrogel contact lenses
Intervention Type
Device
Intervention Name(s)
CLEAR CARE
Intervention Description
Hydrogen peroxide-based cleaning and disinfecting solution
Primary Outcome Measure Information:
Title
Mean Distance Visual Acuity (logMAR) With Study Lenses
Description
Visual acuity (VA) was collected for each eye individually with study lenses in place at a distance of 4 meters using a letter chart. VA was measured in logarithm minimum angle of resolution (logMAR). On Day 30, VA was assessed after 6-8 hours of wear. A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with a lower logMAR value indicating better visual acuity. No formal hypothesis testing was planned.
Time Frame
Day 1, Day 30 after 6-8 hours of wear, each product
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
Able to understand and sign an approved Informed Consent form;
Willing and able to attend all scheduled study visits as required by the protocol;
Current wearer of spherical weekly/monthly soft contact lenses in both eyes with at least 3 months wearing time of 5 days per week and 10 hours per day;
Other protocol-defined inclusion criteria may apply.
Key Exclusion Criteria:
Current or prior Biofinity contact lens wearer in the past 3 months;
Monovision contact lens wearer;
Other protocol-defined exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sr. Clinical Trial Lead, CDMA Vision Care
Organizational Affiliation
Alcon Research, LLC
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
Bloomington
State/Province
Illinois
ZIP/Postal Code
61704
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
Shawnee Mission
State/Province
Kansas
ZIP/Postal Code
66204
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
Clinical Assessment of a Daily Wear Monthly Replacement Soft Silicone Hydrogel Contact Lens
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