DAILIES TOTAL1® Soft Contact Lenses - Post-Market Clinical Follow-up Study
- Conditions
- AstigmatismPresbyopiaMyopiaHyperopia
- Interventions
- Device: Delefilcon A multifocal soft contact lensesDevice: Delefilcon A spherical soft contact lensesDevice: Delefilcon A toric soft contact lenses
- Registration Number
- NCT06483113
- Lead Sponsor
- Alcon Research
- Brief Summary
The purpose of this study is to continuously assess the visual performance and safety of DAILIES TOTAL1 soft contact lenses in a real world setting and broader patient base through routine clinical practices. This activity will be used to continuously support delefilcon A (sphere, toric, and multifocal) soft contact lens regulatory requirements and standards.
- Detailed Description
This study includes a Baseline visit and a Year 1 visit.
The Baseline visit is defined as the first office visit where an eye care professional provided an in-person office biomicroscopy exam to the subject before or during which a DAILIES TOTAL1 sphere, toric, or multifocal soft contact lens prescription was released. The Baseline visit will be retrospective. All assessments at baseline will be obtained from chart reviews.
The Year 1 visit is defined as the visit that occurs 1 year (-2/+4 months) since the Baseline visit during which period the subject is wearing prescribed lenses and a contact lens examination is performed. The Year 1 visit can be either retrospective or prospective in subjects 7 to less than 18 years of age. For subjects 18 years of age and older, the Year 1 visit will be retrospective.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 224
- At baseline: 7 years of age or older for sphere and toric wearers, 40 years of age or older for multifocal wearers.
- Wearers of delefilcon A (sphere, toric, or multifocal) soft contact lenses of the same design in both eyes who have already begun use of the lens type and have purchased at least 3-month supply of lenses at baseline.
- Best corrected distance visual acuity (BCVA) 20/25 or better in each eye at baseline.
- Other protocol-defined inclusion criteria may apply.
Key
- Any ocular disease or condition that would contraindicate contact lens wear at baseline.
- Use of systemic or ocular medications that would contraindicate contact lens wear at baseline.
- Other protocol-defined exclusion criteria may apply.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description DAILIES TOTAL1 Multifocal Delefilcon A multifocal soft contact lenses Delefilcon A multifocal soft contact lenses worn in both eyes in a real-world setting DAILIES TOTAL1 Sphere Delefilcon A spherical soft contact lenses Delefilcon A spherical soft contact lenses worn in both eyes in a real-world setting DAILIES TOTAL1 Toric Delefilcon A toric soft contact lenses Delefilcon A toric soft contact lenses worn in both eyes in a real-world setting
- Primary Outcome Measures
Name Time Method Distance visual acuity (VA) with study lenses at Baseline - Sphere and Toric Baseline Distance VA will be assessed for each eye individually with study lenses in place and recorded in Snellen. This endpoint is prespecified for DAILIES TOTAL1 spherical contact lenses and DAILIES TOTAL1 for Astigmatism contact lenses.
Distance visual acuity with study lenses at Year 1 Follow-up - Sphere and Toric Year 1 Follow-Up Distance VA will be assessed for each eye individually with study lenses in place and recorded in Snellen. This endpoint is prespecified for DAILIES TOTAL1 spherical contact lenses and DAILIES TOTAL1 for Astigmatism contact lenses.
Distance visual acuity with study lenses at Baseline - Multifocal Baseline Distance visual acuity will be assessed for both eyes together with study lenses in place and recorded in Snellen. This endpoint is prespecified for DAILIES TOTAL1 multifocal contact lenses.
Distance visual acuity with study lenses at Year 1 Follow-Up - Multifocal Year 1 Follow-Up Distance visual acuity will be assessed for both eyes together with study lenses in place and recorded in Snellen. This endpoint is prespecified for DAILIES TOTAL1 multifocal contact lenses.
Near visual acuity with study lenses at Baseline - Multifocal Baseline Near visual acuity will be assessed for both eyes together with study lenses in place and recorded in Snellen. This endpoint is prespecified for DAILIES TOTAL1 multifocal contact lenses.
Near visual acuity with study lenses at Year 1 Follow-Up - Multifocal Year 1 Follow-Up Near visual acuity will be assessed for both eyes together with study lenses in place and recorded in Snellen. This endpoint is prespecified for DAILIES TOTAL1 multifocal contact lenses.
Incidence of corneal infiltrative events Up to Year 1 A corneal infiltrate is a single or group of inflammatory cells in the normally clear cornea.
Incidence of microbial keratitis Up to Year 1 Microbial keratitis is a sight-threatening infection of the cornea.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (12)
Complete Eye Care of Medina
🇺🇸Medina, Minnesota, United States
Koetting Associates
🇺🇸Saint Louis, Missouri, United States
Optometry Group, PLLC
🇺🇸Memphis, Tennessee, United States
Southern Utah Medical Research
🇺🇸Saint George, Utah, United States
Scripps Optometric Group
🇺🇸San Diego, California, United States
Dr. Walker and Associates
🇺🇸Ponte Vedra Beach, Florida, United States
Advanced Eyecare Specialists
🇺🇸West Palm Beach, Florida, United States
Cornea and Contact Lens Institute of Minnesota
🇺🇸Edina, Minnesota, United States
Westview Optometry
🇺🇸San Diego, California, United States
The Eye Doctors Inc
🇺🇸Eden Prairie, Minnesota, United States
Center for Ophthalmic and Vision Research
🇺🇸New York, New York, United States
Spokane Eye Clinic
🇺🇸Spokane, Washington, United States