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

Myopia Clinical Trial

Official title:

AONDA Retrospective Study 1

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05790928
• Other study ID #: CLD265-P001
• Status: Completed
• Start date: March 25, 2023
• Est. completion date: March 31, 2023

Study information

• Verified date: May 2023
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: March 31, 2023
• Est. primary completion date: March 31, 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hyperopia
• Myopia
• Refractive Ametropia
• Refractive Errors

Intervention

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

Locations

Country	Name	City	State
United States	The Eye Doctors Inc	Eden Prairie	Minnesota
United States	Franklin Park Eye Center PC	Franklin Park	Illinois
United States	Optometry Group, PLLC	Memphis	Tennessee
United States	Tallahassee Eye Center	Tallahassee	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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