Air Optix® Night and Day® Aqua Continuous Wear

The purpose of this retrospective, Post-Market Clinical Follow-Up (PMCF) study is to assess the long term performance and safety of Air Optix® Night and Day® Aqua (AONDA) contact lenses in a real-world setting when worn as 30 days of continuous wear for vision correction.

Study Overview

• Status: Completed
• Conditions: Refractive Errors
• 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 identify charts within their existing databases in a fair and consistent manner. Subjects/charts meeting the eligibility criteria will be enrolled in the study.

The study is designed with one period. The duration of the period includes the Baseline Visit and the Year 3 Visit as follows:

• The Baseline Visit is defined as the first office visit where an eye care professional provided an in-person office biomicroscopy exam to the subject, before or during which a contact lens prescription for AONDA or PureVision 2 (PV2) was released.
• The Year 3 Visit is defined as a visit which occurred 3 years (-2/+8 months) since Baseline during which period the subject was wearing AONDA contact lenses or PV2 contact lenses and a contact lens examination was performed.

The data collection period is defined as any approximately 3-year timeframe since and including 2009.

• Study Type: Observational
• Enrollment (Actual): 1256

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92123
      • Complete Family Vision Care
  • Florida
    • Jacksonville, Florida, United States, 32246
      • Pearle Vision
    • Miami, Florida, United States, 33126
      • Jackson Health Community Center
    • Orlando, Florida, United States, 32803
      • Vision Health Institute
  • Minnesota
    • Medina, Minnesota, United States, 55340
      • Complete Eye Care of Medina
  • Missouri
    • Saint Louis, Missouri, United States, 63144
      • Koetting Associates
  • New York
    • Vestal, New York, United States, 13850
      • Sacco Eye Group
  • Utah
    • Salt Lake City, Utah, United States, 84117
      • Smith Bowman Ophthalmology

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

Key Inclusion Criteria:

• Manifest refraction cylinder less than or equal to 0.75 diopter in each eye at baseline
• Best corrected visual acuity of 20/25 or better in each eye at baseline
• At the time of Year 3 Visit, subject was prescribed and wearing AONDA or PV2 contact lenses in both eyes in a 30-day continuous wear modality for at least approximately 3 years
• Baseline Visit and Year 3 Visit charts available

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

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 in a 30-day, continuous wear modality (lenses worn continuously including overnight) over a period of approximately 3 years	Device: Lotrafilcon A contact lenses; CE-marked silicone hydrogel contact lenses; Other Names: AONDA; Air Optix® Night and Day® Aqua
PV2 contact lenses; Balafilcon A contact lenses worn in a 30-day, continuous wear modality (lenses worn continuously including overnight) over a period of approximately 3 years	Device: Balafilcon A contact lenses; CE-marked silicone hydrogel contact lenses; Other Names: PureVision® 2; PV2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Distance visual acuity	The subject's chart will be reviewed for distance visual acuity.	Year 3
Incidence of corneal infiltrative events	The subject's chart will be reviewed for incidences of corneal infiltrative events occurring after the Baseline Visit exam.	Up to Year 3
Incidence of microbial keratitis	The subject's chart will be reviewed for incidences of microbial keratitis occurring after the Baseline Visit exam.	Up to Year 3

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 5, 2023
• Primary Completion (Actual): August 22, 2024
• Study Completion (Actual): August 22, 2024

Study Registration Dates

• First Submitted: August 8, 2023
• First Submitted That Met QC Criteria: August 8, 2023
• First Posted (Actual): August 15, 2023

Study Record Updates

• Last Update Posted (Actual): September 19, 2024
• Last Update Submitted That Met QC Criteria: September 17, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Contact Lenses; Overnight wear
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors
• Other Study ID Numbers: CLD265-N003

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