Clinical trial NCT05790928: Air Optix Night and Day Aqua (AONDA) Retrospective Study 1
Official title: AONDA Retrospective Study 1
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Refractive Ametropia
Hyperopia
Myopia
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2023-03-30
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
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 study is to assess long term performance and safety of AONDA in a real world setting when worn as daily wear or continuous wear for vision correction. This study will be used to support AONDA's marketability in Europe and other locations.

Detailed description: In this retrospective observational study, the subject used AONDA for at least approximately 1 year in either a daily wear (DW) or continuous wear (CW) modality with monthly replacement. For the CW cohort only, 3-year data will be collected, if available.

Eligibility criteria: Key Inclusion Criteria:

* Normal eyes, as determined or known by the investigator;
* Manifest refraction cylinder less than or equal to 0.75 diopter (D) in each eye at baseline;
* Best Corrected Visual Acuity (BCVA) of 20/25 Snellen or better in each eye at baseline;
* At the time of the 1-year visit, subject was prescribed and wearing AONDA in both eyes in either a DW or CW modality for at least approximately 1 without changing modality;
* Baseline and 1-year visit chart available;
* Other protocol-specified inclusion criteria may apply.

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;
* Other protocol-specified exclusion criteria may apply.

Primary outcomes:
measure: Distance visual acuity at Year 1 - DW Cohort
timeFrame: Year 1
measure: Distance Visual Acuity at Year 1 - CW Cohort
timeFrame: Year 1
measure: Distance Visual Acuity at Year 3 - CW Cohort
timeFrame: Year 3
measure: Incidence of Corneal Infiltrative Events up to Year 1 - DW Cohort
timeFrame: Up to Year 1
measure: Incidence of Corneal Infiltrative Events up to Year 1 - CW Cohort
timeFrame: Up to Year 1
measure: Incidence of Corneal Infiltrative Events Up to Year 3 - CW Cohort
timeFrame: Up to Year 3
measure: Incidence of Microbial Keratitis up to Year 1 - DW Cohort
timeFrame: Up to Year 1
measure: Incidence of Microbial Keratitis up to Year 1 - CW Cohort
timeFrame: Up to Year 1
measure: Incidence of Microbial Keratitis up to Year 3 - CW Cohort
timeFrame: Up to Year 3
Secondary outcomes:
Other outcomes:
Locations:
city: Tallahassee
country: United States
facility: Tallahassee Eye Center
state: Florida
city: Franklin Park
country: United States
facility: Franklin Park Eye Center PC
state: Illinois
city: Eden Prairie
country: United States
facility: The Eye Doctors Inc
state: Minnesota
city: Memphis
country: United States
facility: Optometry Group, PLLC
state: Tennessee
Study officials:
affiliation: Alcon Research, LLC
name: Clinical Trial Lead, CRD
role: STUDY_DIRECTOR
References: