Air Optix® Night and Day® Aqua Daily Wear

Myopia Clinical Trial

Official title:

Air Optix® Night and Day® Aqua Daily Wear

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05976750
• Other study ID #: CLD265-N002
• Status: Enrolling by invitation
• Start date: October 3, 2023
• Est. completion date: July 2024

Study information

• Verified date: May 2024
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

This is a non-interventional/observational study designed as a retrospective chart review. Study sites will review charts within their existing database to identify subjects who wore AONDA contact lenses or PureVision® 2 (PV2) contact lenses in both eyes for approximately 1 year following their contact lens examination. The data collection period consists of any approximately 1-year timeframe since and including 2009.

The anticipated duration of the study is approximately 6 months.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 110
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Normal eyes, as determined by the Investigator

• At the time of the 1-year visit, subject was prescribed and wearing AONDA contact lenses or PV2 contact lenses in both eyes in a daily wear modality for at least approximately 1 year without changing wear modality

• Baseline and 1-year visit charts available

• Other protocol-specified inclusion criteria may apply

Exclusion Criteria

• Any recurrent history or active anterior segment infection, inflammation, abnormality, or disease contraindicating regular contact lens wear present at Baseline

• Use of systemic or ocular medications contraindicating regular contact lens wear at Baseline

• History of refractive surgery or irregular cornea

• Other protocol-specified exclusion criteria may apply

Related Conditions & MeSH terms

• Hyperopia
• Myopia
• Refractive Errors

Intervention

Device:
• Lotrafilcon A contact lenses
CE-marked silicone hydrogel contact lenses for daily wear use
• Balafilcon A contact lenses
CE-marked silicone hydrogel contact lenses for daily wear use

Locations

Country	Name	City	State
United States	Contact Alcon Call Center for Trial Locations	Fort Worth	Texas

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 by eye	The subject's chart will be reviewed for distance visual acuity.	Year 1
Primary	Incidence of corneal infiltrative events	The subject's chart will be reviewed for incidences of corneal infiltrative events occurring after the baseline exam.	Up to Year 1
Primary	Incidence of microbial keratitis	The subject's chart will be reviewed for incidences of microbial keratitis occurring after the baseline exam.	Up to Year 1