Back to resultsClinical Assessment of Two Reusable Silicone Hydrogel Contact Lenses
Primary Purpose
Refractive Errors
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lehfilcon A contact lenses
Senofilcon A contact lenses
CLEAR CARE
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 a commercial spherical weekly/monthly soft contact lenses 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 in each eye.
- Best corrected distance visual acuity better than or equal to 20/25 Snellen in each eye.
- Other protocol-defined inclusion criteria may apply.
Key Exclusion Criteria:
- Monovision or multifocal lens wearer.
- Habitual senofilcon contact lens wearer (for example, Acuvue Oasys, Acuvue Vita) or commercially available lehfilcon A contact lens wearer (TOTAL30).
- Routinely sleeps in habitual contact lenses.
- Other protocol-defined exclusion criteria may apply.
Sites / Locations
- Dr. Elsa Pao, OD
- Pacific Rims Optometry
- Sabal Eye Care
- Vision Health Institute
- West Bay Eye Associates
- North Spartanburg Eye Center
- Optometry Group, PLLC
- Advancing Vision Research, LLC
- Dr Christina R Chang & Associates, OD, PA
- Dawn M. Rakich, OD
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
LID018869, then AOHP
AOHP, then LID018869
Arm Description
Lehfilcon A contact lenses worn in Period 1, followed by senofilcon A contact lenses worn in Period 2, as randomized. Each product will be worn in both eyes during waking hours only for at least 10 hours per day for 30 days. CLEAR CARE will be used for daily contact lens cleaning and disinfection.
Senofilcon A contact lenses worn in Period 1, followed by lehfilcon A contact lenses worn in Period 2, as randomized. Each product will be worn in both eyes during waking hours only for at least 10 hours per day for 30 days. CLEAR CARE will be used for daily contact lens cleaning and disinfection.
Outcomes
Primary Outcome Measures
Least Squares Mean Distance Visual Acuity With Study Lenses at Day 30
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05050578
Brief Title
Clinical Assessment of Two Reusable Silicone Hydrogel Contact Lenses
Official Title
Clinical Assessment of Two Reusable Silicone Hydrogel Contact Lenses
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
November 2, 2021 (Actual)
Primary Completion Date
February 22, 2022 (Actual)
Study Completion Date
February 22, 2022 (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 compare the clinical performance of LID018869 soft contact with ACUVUE® OASYS with HYDRACLEAR® PLUS (AOHP) soft contact lenses over 30 days of daily wear.
Detailed Description
Subjects will be expected to attend 6 visits. Subjects will be expected to wear their study contact lenses every day for at least 10 hours per day over a 30-day period for each study lens type. The total duration of a subject's participation in the study will be approximately 65 days.
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
ParticipantInvestigator
Allocation
Randomized
Enrollment
166 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LID018869, then AOHP
Arm Type
Other
Arm Description
Lehfilcon A contact lenses worn in Period 1, followed by senofilcon A contact lenses worn in Period 2, as randomized. Each product will be worn in both eyes during waking hours only for at least 10 hours per day for 30 days. CLEAR CARE will be used for daily contact lens cleaning and disinfection.
Arm Title
AOHP, then LID018869
Arm Type
Other
Arm Description
Senofilcon A contact lenses worn in Period 1, followed by lehfilcon A contact lenses worn in Period 2, as randomized. Each product will be worn in both eyes during waking hours only for at least 10 hours per day for 30 days. CLEAR CARE will be used for daily contact lens cleaning and disinfection.
Intervention Type
Device
Intervention Name(s)
Lehfilcon A contact lenses
Other Intervention Name(s)
LID018869
Intervention Description
Commercially available, silicone hydrogel, spherical contact lenses used as indicated
Intervention Type
Device
Intervention Name(s)
Senofilcon A contact lenses
Other Intervention Name(s)
AOHP
Intervention Description
Commercially available, silicone hydrogel, spherical contact lenses used as indicated
Intervention Type
Device
Intervention Name(s)
CLEAR CARE
Intervention Description
Hydrogen peroxide-based contact lens cleaning and disinfecting solution
Primary Outcome Measure Information:
Title
Least Squares Mean Distance Visual Acuity With Study Lenses at Day 30
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.
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:
Current wearer of a commercial spherical weekly/monthly soft contact lenses 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 in each eye.
Best corrected distance visual acuity better than or equal to 20/25 Snellen in each eye.
Other protocol-defined inclusion criteria may apply.
Key Exclusion Criteria:
Monovision or multifocal lens wearer.
Habitual senofilcon contact lens wearer (for example, Acuvue Oasys, Acuvue Vita) or commercially available lehfilcon A contact lens wearer (TOTAL30).
Routinely sleeps in habitual contact lenses.
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
Dr. Elsa Pao, OD
City
Oakland
State/Province
California
ZIP/Postal Code
94607
Country
United States
Facility Name
Pacific Rims Optometry
City
San Francisco
State/Province
California
ZIP/Postal Code
94127
Country
United States
Facility Name
Sabal Eye Care
City
Longwood
State/Province
Florida
ZIP/Postal Code
32779
Country
United States
Facility Name
Vision Health Institute
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
West Bay Eye Associates
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02888
Country
United States
Facility Name
North Spartanburg Eye Center
City
Boiling Springs
State/Province
South Carolina
ZIP/Postal Code
29316
Country
United States
Facility Name
Optometry Group, PLLC
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38111
Country
United States
Facility Name
Advancing Vision Research, LLC
City
Smyrna
State/Province
Tennessee
ZIP/Postal Code
37167
Country
United States
Facility Name
Dr Christina R Chang & Associates, OD, PA
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
Dawn M. Rakich, OD
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78213
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Assessment of Two Reusable Silicone Hydrogel Contact Lenses
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