Air Optix® Night and Day® Aqua Continuous Wear

Alcon Research1,256 enrolled

Overview

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.

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

1,256

Conditions

Refractive Errors

Interventions

Lotrafilcon A contact lensesDEVICE

CE-marked silicone hydrogel contact lenses

Balafilcon A contact lensesDEVICE

CE-marked silicone hydrogel contact lenses

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (8)

Complete Family Vision Care

San Diego, California, United States

Pearle Vision

Jacksonville, Florida, United States

Jackson Health Community Center

Miami, Florida, United States

Vision Health Institute

Orlando, Florida, United States

Outcomes

Primary Outcomes

Distance visual acuity

The subject's chart will be reviewed for distance visual acuity.

Time frame: 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.

Time frame: 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.

Time frame: Up to Year 3

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.