Clinical trial NCT05992675: Air Optix® Night and Day® Aqua Continuous Wear
Official title: Air Optix® Night and Day® Aqua Continuous Wear
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Refractive Errors
Keywords: Contact Lenses
Overnight wear
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2023-08-15
Enrollment: 1256
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Investigators will enroll charts following a pre-identified process.

Brief summary: The purpose of this retrospective, Post-Market Clinical Follow-Up (PMCF) study is to assess the long term performance and safety of Air Optix® Night and Day® Aqua (AONDA) contact lenses in a real-world setting when worn as 30 days of continuous wear for vision correction.

Detailed description: This is a non-interventional/observational study designed as a retrospective chart review. Study sites will identify charts within their existing databases in a fair and consistent manner. Subjects/charts meeting the eligibility criteria will be enrolled in the study.

The study is designed with one period. The duration of the period includes the Baseline Visit and the Year 3 Visit as follows:

* 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 contact lens prescription for AONDA or PureVision 2 (PV2) was released.
* The Year 3 Visit is defined as a visit which occurred 3 years (-2/+8 months) since Baseline during which period the subject was wearing AONDA contact lenses or PV2 contact lenses and a contact lens examination was performed.

The data collection period is defined as any approximately 3-year timeframe since and including 2009.

Eligibility criteria: Key Inclusion Criteria:

* Manifest refraction cylinder less than or equal to 0.75 diopter in each eye at baseline
* Best corrected visual acuity of 20/25 or better in each eye at baseline
* At the time of Year 3 Visit, subject was prescribed and wearing AONDA or PV2 contact lenses in both eyes in a 30-day continuous wear modality for at least approximately 3 years
* Baseline Visit and Year 3 Visit charts available

Key Exclusion Criteria:

* Any recurrent history or active anterior segment infection, inflammation, abnormality, or disease contraindicating regular contact lens wear present at baseline
* The use of systemic or ocular medications contraindicating regular contact lens wear at baseline
* History of refractive surgery or irregular cornea
* Slit lamp findings, including signs of pathological dry eye, that would contraindicate regular contact lens wear at baseline

Primary outcomes:
measure: Distance visual acuity
timeFrame: Year 3
measure: Incidence of corneal infiltrative events
timeFrame: Up to Year 3
measure: Incidence of microbial keratitis
timeFrame: Up to Year 3
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Complete Family Vision Care
state: California
city: Jacksonville
country: United States
facility: Pearle Vision
state: Florida
city: Miami
country: United States
facility: Jackson Health Community Center
state: Florida
city: Orlando
country: United States
facility: Vision Health Institute
state: Florida
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: Vestal
country: United States
facility: Sacco Eye Group
state: New York
city: Salt Lake City
country: United States
facility: Smith Bowman Ophthalmology
state: Utah
Study officials:
affiliation: Alcon Research, LLC
name: Clinical Trial Lead, CRD Vision Care
role: STUDY_DIRECTOR
References: