Air Optix® Night and Day® Aqua Therapeutic 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

168 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-09-26

Study Completion Date

2024-10-25

Brief Summary

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The purpose of this study is to support the safety and performance assessment of Air Optix Night and Day Aqua (AONDA) soft contact lenses for therapeutic use in accordance with updated EU Medical Device Regulation (MDR) requirements.

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Detailed Description

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In this retrospective, real world evidence study, the subjects wore Air Optix Night and Day Aqua (AONDA) soft contact lenses or PureVision 2 (PV2) soft contact lenses as a therapeutic lens for the treatment of a corneal condition with pain in one or both eyes as part of their eye care professional's treatment and management plan.

Conditions

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Bullous Keratopathy Corneal Erosion Entropion Corneal Edema Corneal Dystrophy

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 therapeutically as a bandage lens in a continuous wear (CW) modality (lenses worn continuously including overnight) as instructed by the eye care professional.

Lotrafilcon A contact lenses

Intervention Type DEVICE

CE-marked silicone hydrogel contact lenses

PV2 contact lenses

Balafilcon A contact lenses worn therapeutically as a bandage lens in a continuous wear (CW) modality (lenses worn continuously including overnight) as instructed by the eye care professional.

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

* Diagnosis of a corneal condition with pain for which AONDA or PV2 contact lenses were placed on one or both eye(s) as a therapeutic contact lens at Baseline.
* Baseline and Follow-up (up to 1 year from Baseline) charts available.

Exclusion Criteria

* Had a condition (pathological, behavioral, and/or situational) that contraindicated therapeutic CL wear or confounds study results during the data collection period.
* Used systemic or ocular medication that would confound study results during the data collection period.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No