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

AONDA Retrospective Study 1

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.

Study Overview

• Status: Completed
• Conditions: Myopia; Hyperopia; Refractive Ametropia
• Intervention / Treatment: Device: Lotrafilcon A spherical contact lenses

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.

• Study Type: Observational
• Enrollment (Actual): 108

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tallahassee, Florida, United States, 32308
      • Tallahassee Eye Center
  • Illinois
    • Franklin Park, Illinois, United States, 60131
      • Franklin Park Eye Center PC
  • Minnesota
    • Eden Prairie, Minnesota, United States, 55344
      • The Eye Doctors Inc
  • Tennessee
    • Memphis, Tennessee, United States, 38111
      • Optometry Group, PLLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Investigators will enroll charts following a pre-identified process.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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; Other Names: AIR OPTIX Night & Day AQUA; AONDA
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; 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; Other Names: AIR OPTIX Night & Day AQUA; AONDA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: Clinical Trial Lead, CRD, Alcon Research, LLC

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2023
• Primary Completion (Actual): March 31, 2023
• Study Completion (Actual): March 31, 2023

Study Registration Dates

• First Submitted: March 7, 2023
• First Submitted That Met QC Criteria: March 17, 2023
• First Posted (Actual): March 30, 2023

Study Record Updates

• Last Update Posted (Actual): May 25, 2023
• Last Update Submitted That Met QC Criteria: May 24, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Hyperopia
• Other Study ID Numbers: CLD265-P001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No