Back to resultsClinical Performance Assessment of a Daily Wear Monthly Replacement Soft Silicone Hydrogel Contact Lens
Primary Purpose
Refractive Errors
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lehfilcon A contact lenses
Comfilcon A contact lenses
Multi-purpose disinfection solution
Sponsored by
About this trial
This is an interventional treatment trial for Refractive Errors focused on measuring Contact Lenses
Eligibility Criteria
Inclusion Criteria:
- Sign Informed Consent document.
- Successful wear of spherical weekly/monthly soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months.
- Possess spectacles that provide a corrected visual acuity of 20/40 or better in both eyes.
- Other protocol-specified inclusion criteria may apply.
Exclusion Criteria
- Any eye condition or disease or use of medication that contraindicates contact lens wear.
- Eye surgery, irregular cornea, eye injury as specified in the protocol.
- Routinely sleeps in contact lenses at least 1 night per week over the last 3 months prior to enrollment.
- Any use of topical ocular medications, artificial tear or rewetting drops that would require instillation during contact lens wear.
- Habitually wears Biofinity contact lenses.
- Other protocol-specified exclusion criteria may apply.
Sites / Locations
- Alcon Investigative Site
- Alcon Investigative Site
- Alcon Investigative Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
LID017569, then Biofinity
Biofinity, then LID017569
Arm Description
Lehfilcon A contact lenses worn first, followed by comfilcon A contact lenses, as randomized. Each product will be worn in both eyes on a daily wear basis at least 8 hours a day, 5 days a week, for 30 days. Lenses will be removed nightly for 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 on a daily wear basis at least 8 hours a day, 5 days a week, for 30 days. Lenses will be removed nightly for cleaning and disinfection.
Outcomes
Primary Outcome Measures
Distance VA (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). 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
NCT04055519
Brief Title
Clinical Performance Assessment of a Daily Wear Monthly Replacement Soft Silicone Hydrogel Contact Lens
Official Title
Clinical Performance Assessment of a Daily Wear Monthly Replacement Soft Silicone Hydrogel Contact Lens
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
September 19, 2019 (Actual)
Primary Completion Date
December 3, 2019 (Actual)
Study Completion Date
December 3, 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 is to obtain on-eye performance data to inform contact lens product development.
Detailed Description
Subjects are expected to attend 5 scheduled visits. The expected duration of subject participation in the study is approximately 60 days, with approximately 30 days (± 2 days) per product.
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
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LID017569, 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 on a daily wear basis at least 8 hours a day, 5 days a week, for 30 days. Lenses will be removed nightly for cleaning and disinfection.
Arm Title
Biofinity, then LID017569
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 on a daily wear basis at least 8 hours a day, 5 days a week, for 30 days. Lenses will be removed nightly for cleaning and disinfection.
Intervention Type
Device
Intervention Name(s)
Lehfilcon A contact lenses
Other Intervention Name(s)
LID017569
Intervention Description
Investigational silicone hydrogel contact lenses
Intervention Type
Device
Intervention Name(s)
Comfilcon A contact lenses
Other Intervention Name(s)
Biofinity®
Intervention Description
Commercially available silicone hydrogel contact lenses
Intervention Type
Device
Intervention Name(s)
Multi-purpose disinfection solution
Other Intervention Name(s)
OPTI-FREE® RepleniSH®
Intervention Description
Solution for cleaning, disinfecting, and reconditioning silicone hydrogel contact lenses
Primary Outcome Measure Information:
Title
Distance VA (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). 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 30 after a minimum of 6 hours of wear, each product
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Sign Informed Consent document.
Successful wear of spherical weekly/monthly soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months.
Possess spectacles that provide a corrected visual acuity of 20/40 or better in both eyes.
Other protocol-specified inclusion criteria may apply.
Exclusion Criteria
Any eye condition or disease or use of medication that contraindicates contact lens wear.
Eye surgery, irregular cornea, eye injury as specified in the protocol.
Routinely sleeps in contact lenses at least 1 night per week over the last 3 months prior to enrollment.
Any use of topical ocular medications, artificial tear or rewetting drops that would require instillation during contact lens wear.
Habitually wears Biofinity contact lenses.
Other protocol-specified exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
CDMA Project Lead, 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
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 Performance Assessment of a Daily Wear Monthly Replacement Soft Silicone Hydrogel Contact Lens
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