Clinical Assessment of a Daily Disposable Soft Silicone Hydrogel Contact Lens
- Conditions
- Refractive Errors
- Registration Number
- NCT06044948
- Lead Sponsor
- Alcon Research
- Brief Summary
The purpose of this study is to assess the clinical performance of DAILIES TOTAL1® spherical soft contact lenses over approximately 1 week of daily wear.
- Detailed Description
Subjects will be expected to attend 2 visits (Visit 1 Screen/Baseline/ Dispense; and Visit 2 Week 1 Follow-up/ Exit). The total duration of a subject's participation in the study as well as exposure to the contact lenses will be approximately 1 week (6-8 days of contact lens wear).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 97
- Current wearer of commercial spherical soft contact lenses in both eyes 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 (D) in each eye;
- Best corrected distance visual acuity better than or equal to 20/25 (Snellen) in each eye.
Key
- Current or prior habitual DAILIES TOTAL1 soft contact lens wear in the past 3 months prior to consent;
- Monovision contact lens wear;
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Distance VA With Study Lenses at Week 1 Week 1 Visual acuity (VA) was measured for each eye individually with study lenses on eye using letter charts. VA was recorded in Snellen where 20/20 represents normal distance eyesight and 20/15 represents better than normal eyesight. No hypothesis testing was prespecified for this endpoint.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (6)
Tallahassee Eye Center
🇺🇸Tallahassee, Florida, United States
The Eye Doctors, Inc.
🇺🇸Eden Prairie, Minnesota, United States
Oculus Research, Inc.
🇺🇸Garner, North Carolina, United States
ProCare Vision Center
🇺🇸Granville, Ohio, United States
Wyomissing Optometric Center
🇺🇸Wyomissing, Pennsylvania, United States
Optometry Group, PLLC
🇺🇸Memphis, Tennessee, United States
Tallahassee Eye Center🇺🇸Tallahassee, Florida, United States