Air Optix Night and Day Aqua (AONDA) Retrospective Study 1

NCT05790928 | Completed FDA Device

• 1 other identifier: CLD265-P001
• Study Type: observational
• Target: 108
• Locations: 1 country
• Sites: 4

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.

Conditions

Refractive Ametropia; Hyperopia; Myopia

Outcome Measures

Primary Outcomes (9)

• Distance visual acuity at Year 1 - DW Cohort

  The subject's chart will be reviewed for a distance visual acuity assessment at 1 year after the baseline exam. The 1-year visit will be defined as a visit which occurred 1 year (-2/+4 months) since baseline, during which period the subject was wearing AONDA, and a contact lens examination was performed. Baseline will be defined as the first office visit where the investigator provided an in-person office biomicroscopy exam to the patient, before or during which a contact lens prescription for AONDA was released.

  Year 1

• Distance Visual Acuity at Year 1 - CW Cohort

  The subject's chart will be reviewed for a distance visual acuity assessment at 1 year after the baseline exam. The 1-year visit will be defined as a visit which occurred 1 year (-2/+4 months) since baseline, during which period the subject was wearing AONDA, and a contact lens examination was performed. Baseline will be defined as the first office visit where the investigator provided an in-person office biomicroscopy exam to the patient, before or during which a contact lens prescription for AONDA was released.

  Year 1

• Distance Visual Acuity at Year 3 - CW Cohort

  The subject's chart will be reviewed for a distance visual acuity assessment at 3 years after the baseline exam. The 3-year visit will be defined as a visit which occurred 3 years (-2/+8 months) since baseline, during which period the subject was wearing AONDA and a contact lens examination was performed. The 3-year visit will be applicable only if the chart indicates the subject was wearing AONDA since baseline and 1-year.

  Year 3

• Incidence of Corneal Infiltrative Events up to Year 1 - DW Cohort

  The subject's chart will be reviewed for corneal infiltrative adverse events occurring after the baseline exam. Baseline will be defined as the first office visit where the investigator provided an in-person office biomicroscopy exam to the patient, before or during which a contact lens prescription for AONDA was released.

  Up to Year 1

• Incidence of Corneal Infiltrative Events up to Year 1 - CW Cohort

  The subject's chart will be reviewed for corneal infiltrative adverse events occurring after the baseline exam. Baseline will be defined as the first office visit where the investigator provided an in-person office biomicroscopy exam to the patient, before or during which a contact lens prescription for AONDA was released.

  Up to Year 1

• Incidence of Corneal Infiltrative Events Up to Year 3 - CW Cohort

  The subject's chart will be reviewed for corneal infiltrative adverse events occurring after the baseline exam. Baseline will be defined as the first office visit where the investigator provided an in-person office biomicroscopy exam to the patient, before or during which a contact lens prescription for AONDA was released.

  Up to Year 3

• Incidence of Microbial Keratitis up to Year 1 - DW Cohort

  The subject's chart will be reviewed for incidences of microbial keratitis occurring after the baseline exam. Baseline will be defined as the first office visit where the investigator provided an in-person office biomicroscopy exam to the patient, before or during which a contact lens prescription for AONDA was released.

  Up to Year 1

• Incidence of Microbial Keratitis up to Year 1 - CW Cohort

  The subject's chart will be reviewed for incidences of microbial keratitis occurring after the baseline exam. Baseline will be defined as the first office visit where the investigator provided an in-person office biomicroscopy exam to the patient, before or during which a contact lens prescription for AONDA was released.

  Up to Year 1

• Incidence of Microbial Keratitis up to Year 3 - CW Cohort

  The subject's chart will be reviewed for incidences of microbial keratitis occurring after the baseline exam. Baseline will be defined as the first office visit where the investigator provided an in-person office biomicroscopy exam to the patient, before or during which a contact lens prescription for AONDA was released.

  Up to Year 3

Study Arms (2)

AONDA DW

Lotrafilcon A contact lenses worn in a daily wear (DW) modality (lenses removed nightly for cleaning) for at least 1 year with monthly replacement.

Device: Lotrafilcon A spherical contact lenses

AONDA CW

Lotrafilcon A contact lenses worn in a continuous wear (CW) modality (lenses worn continuously including overnight) for at least 1 year with monthly replacement.

Device: Lotrafilcon A spherical contact lenses

Interventions

Lotrafilcon A spherical contact lenses DEVICE

CE-marked silicone hydrogel contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia) in persons with minimal astigmatism that does not interfere with visual acuity

Also known as: AIR OPTIX Night & Day AQUA, AONDA

AONDA CW; AONDA DW

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Investigators will enroll charts following a pre-identified process.

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (4)

Tallahassee Eye Center

Tallahassee, Florida, 32308, United States

Location

Franklin Park Eye Center PC

Franklin Park, Illinois, 60131, United States

Location

The Eye Doctors Inc

Eden Prairie, Minnesota, 55344, United States

Location

Optometry Group, PLLC

Memphis, Tennessee, 38111, United States

Location

MeSH Terms

Conditions

Hyperopia; Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• Clinical Trial Lead, CRD

  Alcon Research, LLC

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2023
• First Posted: March 30, 2023
• Study Start: March 25, 2023
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: May 25, 2023

Record last verified: 2023-05

Locations

US (4)