Air Optix® Night and Day® Aqua Daily Wear

NCT ID: NCT05976750

Last Updated: 2024-08-09

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

102 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-10-03

Study Completion Date

2024-07-30

Brief Summary

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The purpose of this Post-Market Clinical Follow-Up (PMCF) study is to assess long term performance and safety of Air Optix® Night and Day® Aqua (AONDA) contact lenses in a real-world setting when worn as daily wear for vision correction.

Detailed Description

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This is a non-interventional/observational study designed as a retrospective chart review. Study sites will review charts within their existing database to identify subjects who wore AONDA contact lenses or PureVision® 2 (PV2) contact lenses in both eyes for approximately 1 year following their contact lens examination. The data collection period consists of any approximately 1-year timeframe since and including 2009.

The anticipated duration of the study is approximately 6 months.

Conditions

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Refractive Errors Myopia Hyperopia

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 daily and removed at night for cleaning and disinfection as instructed by the eye care professional

Lotrafilcon A contact lenses

Intervention Type DEVICE

CE-marked silicone hydrogel contact lenses for daily wear use

PV2 contact lenses

Balafilcon A contact lenses worn daily and removed at night for cleaning and disinfection as instructed by the eye care professional

Balafilcon A contact lenses

Intervention Type DEVICE

CE-marked silicone hydrogel contact lenses for daily wear use

Interventions

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Lotrafilcon A contact lenses

CE-marked silicone hydrogel contact lenses for daily wear use

Intervention Type DEVICE

Balafilcon A contact lenses

CE-marked silicone hydrogel contact lenses for daily wear use

Intervention Type DEVICE

Other Intervention Names

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

Eligibility Criteria

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Inclusion Criteria

* Normal eyes, as determined by the Investigator
* At the time of the 1-year visit, subject was prescribed and wearing AONDA contact lenses or PV2 contact lenses in both eyes in a daily wear modality for at least approximately 1 year without changing wear modality
* Baseline and 1-year 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
* Use of systemic or ocular medications contraindicating regular contact lens wear at Baseline
* History of refractive surgery or irregular cornea
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alcon Research

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trial Lead, CRD Vision Care

Role: STUDY_DIRECTOR

Alcon Research, LLC

Locations

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Contact Alcon Call Center for Trial Locations

Fort Worth, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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CLD265-N002

Identifier Type: -

Identifier Source: org_study_id

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