AONDA Therapeutic Indication Study I

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

55 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-06-28

Study Completion Date

2023-07-10

Brief Summary

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This study will be used to support assessment of AIR OPTIX® NIGHT \& DAY® AQUA (AONDA) Soft Contact Lenses' safety and performance in accordance with updated European Union Medical Device Regulation (EU MDR) requirements.

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Detailed Description

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In this retrospective observational study, the subject wore AONDA as a therapeutic lens for the treatment of a corneal condition with pain in one or both eyes.

Conditions

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Bullous Keratopathy Corneal Erosion Entropion Corneal Edema Corneal Dystrophy Corneal Ulcer Foreign Body in Cornea Bell Palsy Keratoconjunctivitis Filamentary Keratitis Sicca Syndrome; Keratoconjunctivitis (Etiology)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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AONDA Therapeutic

Lotrafilcon A contact lenses worn therapeutically as a bandage lens as instructed by the eye care professional

Lotrafilcon 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

Other Intervention Names

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AONDA AIR OPTIX® NIGHT & DAY® AQUA

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of a corneal condition with pain for which AONDA Soft Contact Lens as a therapeutic contact lens was placed on one or both eye(s) 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 contact lens wear or confounds study results during the data collection period, as determined or known by the Investigator.
* Used systemic or ocular medication that would confound study results during the data collection period, as determined or known by the Investigator.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No