Air Optix® Night and Day® Aqua Continuous Wear

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1256 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-10-05

Study Completion Date

2024-08-22

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Refractive Errors

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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

Lotrafilcon A contact lenses

Intervention Type DEVICE

CE-marked silicone hydrogel contact lenses

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

Balafilcon A contact lenses

Intervention Type DEVICE

CE-marked silicone hydrogel contact lenses

Interventions

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Lotrafilcon A contact lenses

CE-marked silicone hydrogel contact lenses

Intervention Type DEVICE

Balafilcon A contact lenses

CE-marked silicone hydrogel contact lenses

Intervention Type DEVICE

Other Intervention Names

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Air Optix® Night and Day® Aqua AONDA PureVision® 2 PV2

Eligibility Criteria

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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

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No