Air Optix Night and Day Aqua (AONDA) Retrospective Study 1

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

108 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-25

Study Completion Date

2023-03-31

Brief Summary

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The purpose of this study is to assess long term performance and safety of AONDA in a real world setting when worn as daily wear or continuous wear for vision correction. This study will be used to support AONDA's marketability in Europe and other locations.

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Detailed Description

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In this retrospective observational study, the subject used AONDA for at least approximately 1 year in either a daily wear (DW) or continuous wear (CW) modality with monthly replacement. For the CW cohort only, 3-year data will be collected, if available.

Conditions

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Refractive Ametropia Hyperopia Myopia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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AONDA DW

Lotrafilcon A contact lenses worn in a daily wear (DW) modality (lenses removed nightly for cleaning) for at least 1 year with monthly replacement.

Lotrafilcon A spherical contact lenses

Intervention Type DEVICE

CE-marked silicone hydrogel contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia) in persons with minimal astigmatism that does not interfere with visual acuity

AONDA CW

Lotrafilcon A contact lenses worn in a continuous wear (CW) modality (lenses worn continuously including overnight) for at least 1 year with monthly replacement.

Lotrafilcon A spherical contact lenses

Intervention Type DEVICE

CE-marked silicone hydrogel contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia) in persons with minimal astigmatism that does not interfere with visual acuity

Interventions

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Lotrafilcon A spherical contact lenses

CE-marked silicone hydrogel contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia) in persons with minimal astigmatism that does not interfere with visual acuity

Intervention Type DEVICE

Other Intervention Names

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AIR OPTIX Night & Day AQUA AONDA

Eligibility Criteria

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Inclusion Criteria

* Normal eyes, as determined or known by the investigator;
* Manifest refraction cylinder less than or equal to 0.75 diopter (D) in each eye at baseline;
* Best Corrected Visual Acuity (BCVA) of 20/25 Snellen or better in each eye at baseline;
* At the time of the 1-year visit, subject was prescribed and wearing AONDA in both eyes in either a DW or CW modality for at least approximately 1 without changing modality;
* Baseline and 1-year visit chart 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