Air Optix® Night and Day® Aqua Continuous Wear

Alcon

Status: Completed

Conditions: Refractive Errors

Treatments: Device: Lotrafilcon A contact lenses; Device: Balafilcon A contact lenses

Study type: Observational

Funder types: Industry

Identifiers

NCT05992675

CLD265-N003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,256 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

1,256 participants in 2 patient groups

AONDA contact lenses

Description:

Lotrafilcon A contact lenses worn in a 30-day, continuous wear modality (lenses worn continuously including overnight) over a period of approximately 3 years

Treatment:

Device: Lotrafilcon A contact lenses

PV2 contact lenses

Description:

Balafilcon A contact lenses worn in a 30-day, continuous wear modality (lenses worn continuously including overnight) over a period of approximately 3 years

Treatment:

Device: Balafilcon A contact lenses