Clinical trial NCT06408649: Post-market Clinical Follow-up Study of Alcon TOTAL30® Contact Lenses (Lehfilcon A)
Official title: Post-market Clinical Follow-up Study of Alcon TOTAL30® Spherical Contact Lenses (Lehfilcon A) and TOTAL30® for Astigmatism Contact Lenses (Lehfilcon A)
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Ametropia
Myopia
Hyperopia
Astigmatism
Keywords: Contact lenses
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2024-05-10
Enrollment: 168
Sex: ALL
Minimum age (years): 7
Standard ages: CHILD
ADULT
OLDER_ADULT
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 Post-Market Clinical Follow-Up (PMCF) study is to continuously assess the visual performance and safety of TOTAL30 Sphere and TOTAL30 for Astigmatism contact lenses in a real-world setting across a broad variety of patients through routine clinical practices.

Detailed description: 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 TOTAL30 sphere or toric contact lens prescription was released. Baseline visit data will be collected retrospectively (chart review).

The Year 1 visit is defined as the visit that occurs 1 year (-2/+6 months) since the Baseline visit during which period the subject is wearing test lenses of the same design in both eyes, and a contact lens examination is performed. Year 1 data will be collected either retrospectively or prospectively (eye exam).

Eligibility criteria: Key Inclusion Criteria:

* Wearers of lehfilcon A (sphere or toric) 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 the baseline timepoint;
* Best corrected spectacle visual acuity (VA) 20/25 or better at baseline;
* Healthy, non-diseased eyes;
* Other protocol-specified inclusion criteria may apply.

Key Exclusion Criteria, as determined or known by the Investigator:

* Any ocular disease or condition that would contraindicate contact lens wear present at baseline;
* The use of systemic or ocular medications that would contraindicate contact lens wear at baseline;
* Participation in a contact lens or contact lens care product clinical trial during the period of the retrospective chart collection or during prospective study participation;
* Other protocol-specified exclusion criteria may apply.

Primary outcomes:
measure: Distance visual acuity with study lenses at baseline
timeFrame: Baseline
measure: Distance visual acuity with study lenses at 1-year follow-up
timeFrame: Year 1
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: Fort Worth
country: United States
facility: Contact Alcon Call Center for Trial Locations
state: Texas
Study officials:
affiliation: Alcon Research, LLC
name: Clinical Trial Lead, Vision Care
role: STUDY_DIRECTOR
References: