Air Optix® Night and Day® Aqua Daily Wear

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.

Study Overview

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

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 102

Contacts and Locations

Study Locations

• United States
  • Texas
    • Fort Worth, Texas, United States, 76134
      • Contact Alcon Call Center for Trial Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Investigators will enroll charts following a pre-identified process.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
AONDA contact lenses; Lotrafilcon A contact lenses worn daily and removed at night for cleaning and disinfection as instructed by the eye care professional	Device: Lotrafilcon A contact lenses; CE-marked silicone hydrogel contact lenses for daily wear use; Other Names: AONDA; Air Optix® Night and Day® Aqua
PV2 contact lenses; Balafilcon A contact lenses worn daily and removed at night for cleaning and disinfection as instructed by the eye care professional	Device: Balafilcon A contact lenses; CE-marked silicone hydrogel contact lenses for daily wear use; Other Names: PureVision® 2; PV2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Distance visual acuity by eye	The subject's chart will be reviewed for distance visual acuity.	Year 1

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): October 3, 2023
• Primary Completion (Actual): July 30, 2024
• Study Completion (Actual): July 30, 2024

Study Registration Dates

• First Submitted: July 26, 2023
• First Submitted That Met QC Criteria: July 26, 2023
• First Posted (Actual): August 4, 2023

Study Record Updates

• Last Update Posted (Actual): August 9, 2024
• Last Update Submitted That Met QC Criteria: August 7, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Hyperopia
• Other Study ID Numbers: CLD265-N002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes