Back to resultsClinical Performance Evaluation of Two Frequent Replacement Silicone Hydrogel Toric Contact Lenses
Primary Purpose
Ametropia, Myopia, Hyperopia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Serafilcon A toric contact lenses
Senofilcon A toric contact lenses
CLEAR CARE
Sponsored by
About this trial
This is an interventional other trial for Ametropia
Eligibility Criteria
Key Inclusion Criteria: Successful wearers of any commercial soft toric contact lenses (except AOfAHP and daily disposable lenses) in both eyes with at least 3 months wearing experience, with a minimum wearing time of 5 days per week and 10 hours per day. Able to be fit with and wear contact lenses within the available range of sphere & cylinder power and axes. Best corrected distance visual acuity greater than or equal to 20/25 Snellen (0.10 logMAR) in each eye as determined by manifest refraction at screening. Other protocol-defined inclusion criteria may apply. Key Exclusion Criteria: Wearing habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment. Habitual AOfAHP contact lens wearers and habitual daily disposable lens wearers (worn within last 3 months). Other exclusion criteria may apply.
Sites / Locations
- Dr. Elsa Pao, OD
- Pacific Rims Optometry
- Drs. Giedd, P.A.
- Vision Health Institute
- Franklin Park Eye Center, PC
- ProCare Vision Centers, Inc.
- Optometry Group, PLLC
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
LID226397, then AOfAHP
AOfAHP, then LID226397
Arm Description
Serafilcon A toric contact lenses worn in Period 1, with senofilcon A toric contact lenses worn in Period 2. Each product will be worn bilaterally (in both eyes) during waking hours for approximately 14 days. CLEAR CARE will be used for nightly contact lens cleaning and disinfection.
Senofilcon A toric contact lenses worn in Period 1, with serafilcon A toric contact lenses worn in Period 2. Each product will be worn bilaterally (in both eyes) during waking hours for approximately 14 days. CLEAR CARE will be used for nightly contact lens cleaning and disinfection.
Outcomes
Primary Outcome Measures
Percentage of lenses with axis orientation within ± 30 degrees from the intended axis at 10 minutes after lens insertion
The investigator will view the contact lens through a slit lamp (biomicroscope) and record the axis orientation (-179° to +180°) as the number of degrees away from the ideal location (90° axis) either positive or negative depending on the direction (nasal [+] or temporal [-]).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05959200
Brief Title
Clinical Performance Evaluation of Two Frequent Replacement Silicone Hydrogel Toric Contact Lenses
Official Title
Clinical Performance Evaluation of Two Frequent Replacement Silicone Hydrogel Toric Contact Lenses
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
August 14, 2023 (Actual)
Primary Completion Date
October 23, 2023 (Actual)
Study Completion Date
October 23, 2023 (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
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The primary objective of this study is to evaluate the axis orientation of LID226397 toric contact lenses.
Detailed Description
Subjects will be expected to attend 7 visits including a screening visit. The total duration of a subject's participation in the study will be approximately 40 days.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ametropia, Myopia, Hyperopia, Astigmatism
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
92 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LID226397, then AOfAHP
Arm Type
Other
Arm Description
Serafilcon A toric contact lenses worn in Period 1, with senofilcon A toric contact lenses worn in Period 2. Each product will be worn bilaterally (in both eyes) during waking hours for approximately 14 days. CLEAR CARE will be used for nightly contact lens cleaning and disinfection.
Arm Title
AOfAHP, then LID226397
Arm Type
Other
Arm Description
Senofilcon A toric contact lenses worn in Period 1, with serafilcon A toric contact lenses worn in Period 2. Each product will be worn bilaterally (in both eyes) during waking hours for approximately 14 days. CLEAR CARE will be used for nightly contact lens cleaning and disinfection.
Intervention Type
Device
Intervention Name(s)
Serafilcon A toric contact lenses
Other Intervention Name(s)
LID226397
Intervention Description
Silicone hydrogel contact lenses for the optical correction of refractive ametropia (myopia or hyperopia with astigmatism)
Intervention Type
Device
Intervention Name(s)
Senofilcon A toric contact lenses
Other Intervention Name(s)
ACUVUE® OASYS for ASTIGMATISM with HYDRACLEAR® PLUS, AOfAHP
Intervention Description
Silicone hydrogel contact lenses for the optical correction of refractive ametropia (myopia or hyperopia with astigmatism)
Intervention Type
Device
Intervention Name(s)
CLEAR CARE
Other Intervention Name(s)
CLEAR CARE® Cleaning and Disinfecting Solution
Intervention Description
Hydrogen peroxide-based contact lens cleaning and disinfecting solution
Primary Outcome Measure Information:
Title
Percentage of lenses with axis orientation within ± 30 degrees from the intended axis at 10 minutes after lens insertion
Description
The investigator will view the contact lens through a slit lamp (biomicroscope) and record the axis orientation (-179° to +180°) as the number of degrees away from the ideal location (90° axis) either positive or negative depending on the direction (nasal [+] or temporal [-]).
Time Frame
Day 1 Dispense, 10 minutes after lens insertion, for each wear period. Each wear period is approximately 14 days.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
Successful wearers of any commercial soft toric contact lenses (except AOfAHP and daily disposable lenses) in both eyes with at least 3 months wearing experience, with a minimum wearing time of 5 days per week and 10 hours per day.
Able to be fit with and wear contact lenses within the available range of sphere & cylinder power and axes.
Best corrected distance visual acuity greater than or equal to 20/25 Snellen (0.10 logMAR) in each eye as determined by manifest refraction at screening.
Other protocol-defined inclusion criteria may apply.
Key Exclusion Criteria:
Wearing habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment.
Habitual AOfAHP contact lens wearers and habitual daily disposable lens wearers (worn within last 3 months).
Other exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trial Lead, CRD 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
Drs. Giedd, P.A.
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
Vision Health Institute
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Franklin Park Eye Center, PC
City
Franklin Park
State/Province
Illinois
ZIP/Postal Code
60131
Country
United States
Facility Name
ProCare Vision Centers, Inc.
City
Granville
State/Province
Ohio
ZIP/Postal Code
43023
Country
United States
Facility Name
Optometry Group, PLLC
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 Evaluation of Two Frequent Replacement Silicone Hydrogel Toric Contact Lenses
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