Clinical trial NCT06483113: DAILIES TOTAL1® Soft Contact Lenses - Post-Market Clinical Follow-up Study
Official title: DAILIES TOTAL1® Soft Contact Lenses - Post-Market Clinical Follow-up Study
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Myopia
Hyperopia
Presbyopia
Astigmatism
Keywords: Contact lenses
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2024-07-03
Enrollment: 224
Sex: ALL
Minimum age (years): 7
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will be recruited from clinical sites located in the United States.

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.

Eligibility criteria: Key Inclusion Criteria:

* 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 Exclusion Criteria:

* 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.

Primary outcomes:
measure: Distance visual acuity (VA) with study lenses at Baseline - Sphere and Toric
timeFrame: Baseline
measure: Distance visual acuity with study lenses at Year 1 Follow-up - Sphere and Toric
timeFrame: Year 1 Follow-Up
measure: Distance visual acuity with study lenses at Baseline - Multifocal
timeFrame: Baseline
measure: Distance visual acuity with study lenses at Year 1 Follow-Up - Multifocal
timeFrame: Year 1 Follow-Up
measure: Near visual acuity with study lenses at Baseline - Multifocal
timeFrame: Baseline
measure: Near visual acuity with study lenses at Year 1 Follow-Up - Multifocal
timeFrame: Year 1 Follow-Up
measure: Incidence of corneal infiltrative events
timeFrame: Up to Year 1
measure: Incidence of microbial keratitis
timeFrame: Up to Year 1
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Westview Optometry
state: California
city: San Diego
country: United States
facility: Scripps Optometric Group
state: California
city: Ponte Vedra Beach
country: United States
facility: Dr. Walker and Associates
state: Florida
city: West Palm Beach
country: United States
facility: Advanced Eyecare Specialists
state: Florida
city: Eden Prairie
country: United States
facility: The Eye Doctors Inc
state: Minnesota
city: Edina
country: United States
facility: Cornea and Contact Lens Institute of Minnesota
state: Minnesota
city: Medina
country: United States
facility: Complete Eye Care of Medina
state: Minnesota
city: Saint Louis
country: United States
facility: Koetting Associates
state: Missouri
city: New York
country: United States
facility: Center for Ophthalmic and Vision Research
state: New York
city: Memphis
country: United States
facility: Optometry Group, PLLC
state: Tennessee
city: Saint George
country: United States
facility: Southern Utah Medical Research
state: Utah
city: Spokane
country: United States
facility: Spokane Eye Clinic
state: Washington
Study officials:
affiliation: Alcon Research, LLC
name: Clinical Trial Lead, Vision Care
role: STUDY_DIRECTOR
References: