Back to resultsClinical Comparison of Two Daily Wear Frequent Replacement Silicone Hydrogel Soft Contact Lenses
Primary Purpose
Refractive Errors, Ametropia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lehfilcon A contact lenses
Senofilcon A contact lenses
Comfilcon A contact lenses
Hydrogen peroxide-based cleaning and disinfecting solution
Sponsored by
About this trial
This is an interventional treatment trial for Refractive Errors focused on measuring Contact Lenses
Eligibility Criteria
Key Inclusion Criteria:
- Sign an approved Informed Consent Form.
- Wear spherical contact lenses in both eyes for a minimum of 5 days per week and 10 hours per day during the past 3 months.
- Willing to wear habitual spectacles for vision correction when study lenses are not worn, as needed.
- Other protocol-defined inclusion criteria may apply.
Key Exclusion Criteria:
- Any eye condition or use of medication that contraindicates contact lens wear, as determined by the Investigator.
- History of refractive surgery or plan to have refractive surgery during the study.
- Current or history of dry eye in either eye that, in the opinion of the Investigator, would preclude contact lens wear.
- Routinely sleeps in contact lenses at least 1 night per week.
- Part A: Current wearer of ACUVUE OASYS® with HYDRACLEAR® PLUS.
- Part B: Current wearer of Biofinity family of contact lenses (comfilcon A).
- Other protocol-defined exclusion criteria may apply.
Sites / Locations
- Alcon Investigator 6356
- Alcon Investigator 6565
- Alcon Investigator 6401
- Alcon Investigator 6353
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Other
Active Comparator
Arm Label
LID018869, then AOHP (Part A)
AOHP, then LID018869 (Part A)
Biofinity (Part B)
Arm Description
Lehfilcon A contact lenses worn first, followed by senofilcon A contact lenses, as randomized. Each product will be worn bilaterally (in both eyes) for approximately 30 days, with a scheduled visit at approximately Day 15 of each wear period. Lenses will be removed nightly for cleaning and disinfection with CLEAR CARE contact lens solution.
Senofilcon A contact lenses worn first, followed by lehfilcon A contact lenses, as randomized. Each product will be worn bilaterally (in both eyes) for approximately 30 days, with a scheduled visit at approximately Day 15 of each wear period. Lenses will be removed nightly for cleaning and disinfection with CLEAR CARE contact lens solution.
Comfilcon A contact lenses worn bilaterally (in both eyes) for approximately 30 days, with a scheduled visit at approximately Day 15 of the wear period. Lenses will be removed nightly for cleaning and disinfection with CLEAR CARE contact lens solution.
Outcomes
Primary Outcome Measures
Distance Visual Acuity (VA) (Part A)
Distance VA was assessed with study lenses in place. VA was collected for each eye separately using logarithmic of the Minimum Angle of Resolution (logMAR) charts. A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity (normal visual acuity), with a negative value denoting better than 20/20 visual acuity. No formal hypothesis testing was predefined for the primary endpoint. The primary endpoint was prespecified for Part A only.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04532099
Brief Title
Clinical Comparison of Two Daily Wear Frequent Replacement Silicone Hydrogel Soft Contact Lenses
Official Title
Clinical Comparison of Two Daily Wear Frequent Replacement Silicone Hydrogel Soft Contact Lenses
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
September 9, 2020 (Actual)
Primary Completion Date
May 4, 2021 (Actual)
Study Completion Date
May 4, 2021 (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 primary objective of this study is to evaluate the overall performance of an investigational silicone hydrogel lens when compared to ACUVUE OASYS® with HYDRACLEAR® PLUS (AOHP).
Detailed Description
Part A of this study is a randomized, double masked, crossover study comparing 2 contact lens products. The expected duration of subject participation in Part A is approximately 8 weeks with 5 scheduled visits.
Part B of this study is a non-randomized, single masked, single group study with 1 contact lens product. The expected duration of subject participation in Part B is approximately 4 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, Ametropia
Keywords
Contact Lenses
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Part A is a crossover study. Part B is a single group study.
Masking
ParticipantInvestigator
Masking Description
Part A is double masked. Part B is single masked (trial subject).
Allocation
Randomized
Enrollment
132 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LID018869, then AOHP (Part A)
Arm Type
Other
Arm Description
Lehfilcon A contact lenses worn first, followed by senofilcon A contact lenses, as randomized. Each product will be worn bilaterally (in both eyes) for approximately 30 days, with a scheduled visit at approximately Day 15 of each wear period. Lenses will be removed nightly for cleaning and disinfection with CLEAR CARE contact lens solution.
Arm Title
AOHP, then LID018869 (Part A)
Arm Type
Other
Arm Description
Senofilcon A contact lenses worn first, followed by lehfilcon A contact lenses, as randomized. Each product will be worn bilaterally (in both eyes) for approximately 30 days, with a scheduled visit at approximately Day 15 of each wear period. Lenses will be removed nightly for cleaning and disinfection with CLEAR CARE contact lens solution.
Arm Title
Biofinity (Part B)
Arm Type
Active Comparator
Arm Description
Comfilcon A contact lenses worn bilaterally (in both eyes) for approximately 30 days, with a scheduled visit at approximately Day 15 of the wear period. Lenses will be removed nightly for cleaning and disinfection with CLEAR CARE contact lens solution.
Intervention Type
Device
Intervention Name(s)
Lehfilcon A contact lenses
Other Intervention Name(s)
LID018869
Intervention Description
Investigational soft contact lenses for daily wear worn in Part A of the study
Intervention Type
Device
Intervention Name(s)
Senofilcon A contact lenses
Other Intervention Name(s)
AOHP, ACUVUE OASYS® with HYDRACLEAR® PLUS
Intervention Description
Commercially available soft contact lenses for daily wear worn in Part A of the study
Intervention Type
Device
Intervention Name(s)
Comfilcon A contact lenses
Other Intervention Name(s)
CooperVision® Biofinity®
Intervention Description
Commercially available soft contact lenses for daily wear worn in Part B of the study
Intervention Type
Device
Intervention Name(s)
Hydrogen peroxide-based cleaning and disinfecting solution
Other Intervention Name(s)
CLEAR CARE®
Intervention Description
For nightly cleaning and disinfecting of contact lenses in Part A and Part B of the study
Primary Outcome Measure Information:
Title
Distance Visual Acuity (VA) (Part A)
Description
Distance VA was assessed with study lenses in place. VA was collected for each eye separately using logarithmic of the Minimum Angle of Resolution (logMAR) charts. A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity (normal visual acuity), with a negative value denoting better than 20/20 visual acuity. No formal hypothesis testing was predefined for the primary endpoint. The primary endpoint was prespecified for Part A only.
Time Frame
Day 30, each study lens type
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
Sign an approved Informed Consent Form.
Wear spherical contact lenses in both eyes for a minimum of 5 days per week and 10 hours per day during the past 3 months.
Willing to wear habitual spectacles for vision correction when study lenses are not worn, as needed.
Other protocol-defined inclusion criteria may apply.
Key Exclusion Criteria:
Any eye condition or use of medication that contraindicates contact lens wear, as determined by the Investigator.
History of refractive surgery or plan to have refractive surgery during the study.
Current or history of dry eye in either eye that, in the opinion of the Investigator, would preclude contact lens wear.
Routinely sleeps in contact lenses at least 1 night per week.
Part A: Current wearer of ACUVUE OASYS® with HYDRACLEAR® PLUS.
Part B: Current wearer of Biofinity family of contact lenses (comfilcon A).
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 Investigator 6356
City
Longwood
State/Province
Florida
ZIP/Postal Code
32779
Country
United States
Facility Name
Alcon Investigator 6565
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
Alcon Investigator 6401
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02888
Country
United States
Facility Name
Alcon Investigator 6353
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 Comparison of Two Daily Wear Frequent Replacement Silicone Hydrogel Soft Contact Lenses
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