Back to resultsClinical Assessment of Two Daily Wear Reusable Soft Silicone Hydrogel Contact Lenses
Primary Purpose
Refractive Errors
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Lehfilcon A contact lenses
Senofilcon A contact lenses
AOSEPT PLUS with HydraGlyde
Sponsored by
About this trial
This is an interventional treatment trial for Refractive Errors focused on measuring Contact Lenses, Myopia
Eligibility Criteria
Key Inclusion Criteria:
- Currently wearing any commercial spherical soft contact lenses with at least 3 months wearing experience.
- Willing to wear the study lenses for a minimum of 5 days per week and 8 hours per day.
- Willing to NOT use rewetting/lubricating drops at any time during the study.
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
- Participation in a clinical trial within the previous 14 days or currently enrolled in any clinical trial.
- Habitual AOHP contact lens wearers (in the past 3 months).
- Monovision wear during the study.
- Other protocol-defined exclusion criteria may apply.
Sites / Locations
- Eurolens Research
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
TOTAL30, then AOHP
AOHP, then TOTAL30
Arm Description
Lehfilcon A contact lenses worn first, with senofilcon A contact lenses worn second, as randomized. The lehfilcon A contact lenses will be worn for approximately 28 days. The senofilcon A contact lenses will be worn for approximately 14 days. Lenses will be worn bilaterally (in both eyes) in a daily wear modality, with AOSEPT PLUS with HydraGlyde used for nightly cleaning and disinfection.
Senofilcon A contact lenses worn first, with lehfilcon A contact lenses worn second, as randomized. The senofilcon A contact lenses will be worn for approximately 14 days. The lehfilcon A contact lenses will be worn for approximately 28 days. Lenses will be worn bilaterally (in both eyes) in a daily wear modality, with AOSEPT PLUS with HydraGlyde used for nightly cleaning and disinfection.
Outcomes
Primary Outcome Measures
Distance VA (logMAR) With Study Lenses
Distance visual acuity (VA) was assessed for each eye individually with study lenses in place using letter charts. 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 lower logMAR values indicating better visual acuity. The follow-up visit for TOTAL 30 occurred approximately 28 days after the baseline visit. The follow-up visit for AOHP occurred approximately 14 days after the baseline visit. No formal hypothesis was formulated for the primary effectiveness endpoint of distance VA; hence, no inferential testing was performed.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05056987
Brief Title
Clinical Assessment of Two Daily Wear Reusable Soft Silicone Hydrogel Contact Lenses
Official Title
Clinical Assessment of Two Daily Wear Reusable Soft Silicone Hydrogel Contact Lenses
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
January 12, 2022 (Actual)
Primary Completion Date
June 14, 2022 (Actual)
Study Completion Date
June 14, 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.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
The overall objective of this clinical study is to describe the clinical performance of the TOTAL30® soft contact lens compared to the ACUVUE® OASYS® with HYDRACLEAR PLUS (AOHP) soft contact lens in a daily wear modality.
Detailed Description
Subjects will be expected to attend 3 visits and wear the study contact lenses at least 5 days per week and at least 8 hours per day. On Visits 2 and 3, subjects will be expected to wear the study lenses at least 6 hours prior to the study visit. The expected total duration of subject participation in the study will be approximately 1.5 months. This study will be conducted in the United Kingdom (UK).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractive Errors
Keywords
Contact Lenses, Myopia
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
TOTAL30, then AOHP
Arm Type
Other
Arm Description
Lehfilcon A contact lenses worn first, with senofilcon A contact lenses worn second, as randomized. The lehfilcon A contact lenses will be worn for approximately 28 days. The senofilcon A contact lenses will be worn for approximately 14 days. Lenses will be worn bilaterally (in both eyes) in a daily wear modality, with AOSEPT PLUS with HydraGlyde used for nightly cleaning and disinfection.
Arm Title
AOHP, then TOTAL30
Arm Type
Other
Arm Description
Senofilcon A contact lenses worn first, with lehfilcon A contact lenses worn second, as randomized. The senofilcon A contact lenses will be worn for approximately 14 days. The lehfilcon A contact lenses will be worn for approximately 28 days. Lenses will be worn bilaterally (in both eyes) in a daily wear modality, with AOSEPT PLUS with HydraGlyde used for nightly cleaning and disinfection.
Intervention Type
Device
Intervention Name(s)
Lehfilcon A contact lenses
Other Intervention Name(s)
TOTAL30®
Intervention Description
CE-marked spherical soft contact lenses worn according to to the product package insert/Instructions for Use
Intervention Type
Device
Intervention Name(s)
Senofilcon A contact lenses
Other Intervention Name(s)
ACUVUE OASYS® with HYDRACLEAR® Plus, AOHP
Intervention Description
CE-marked spherical soft contact lenses worn according to to the product package insert/Instructions for Use
Intervention Type
Device
Intervention Name(s)
AOSEPT PLUS with HydraGlyde
Other Intervention Name(s)
AOSEPT® PLUS with HYDRAGLYDE®
Intervention Description
Hydrogen peroxide-based cleaning and disinfecting solution
Primary Outcome Measure Information:
Title
Distance VA (logMAR) With Study Lenses
Description
Distance visual acuity (VA) was assessed for each eye individually with study lenses in place using letter charts. 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 lower logMAR values indicating better visual acuity. The follow-up visit for TOTAL 30 occurred approximately 28 days after the baseline visit. The follow-up visit for AOHP occurred approximately 14 days after the baseline visit. No formal hypothesis was formulated for the primary effectiveness endpoint of distance VA; hence, no inferential testing was performed.
Time Frame
Dispense (Day 0) and Follow-Up (Day 28 for TOTAL30, Day 14 for AOHP) (each wear period)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
Currently wearing any commercial spherical soft contact lenses with at least 3 months wearing experience.
Willing to wear the study lenses for a minimum of 5 days per week and 8 hours per day.
Willing to NOT use rewetting/lubricating drops at any time during the study.
Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
Participation in a clinical trial within the previous 14 days or currently enrolled in any clinical trial.
Habitual AOHP contact lens wearers (in the past 3 months).
Monovision wear during the study.
Other protocol-defined exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trial Lead, Vision Care
Organizational Affiliation
Alcon Research, LLC
Official's Role
Study Director
Facility Information:
Facility Name
Eurolens Research
City
Manchester
ZIP/Postal Code
M13 9PL
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Assessment of Two Daily Wear Reusable Soft Silicone Hydrogel Contact Lenses
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