Air Optix® Night and Day® Aqua Daily Wear

NCT05976750 | Completed FDA Device

• 1 other identifier: CLD265-N002
• Study Type: observational
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Refractive Errors; Myopia; Hyperopia

Outcome Measures

Primary Outcomes (3)

• Distance visual acuity by eye

  The subject's chart will be reviewed for distance visual acuity.

  Year 1

• Incidence of corneal infiltrative events

  The subject's chart will be reviewed for incidences of corneal infiltrative events occurring after the baseline exam.

  Up to Year 1

• Incidence of microbial keratitis

  The subject's chart will be reviewed for incidences of microbial keratitis occurring after the baseline exam.

  Up to Year 1

Study Arms (2)

AONDA contact lenses

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

Device: Lotrafilcon A contact lenses

PV2 contact lenses

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

Device: Balafilcon A contact lenses

Interventions

Lotrafilcon A contact lenses DEVICE

CE-marked silicone hydrogel contact lenses for daily wear use

Also known as: AONDA, Air Optix® Night and Day® Aqua

AONDA contact lenses

Balafilcon A contact lenses DEVICE

CE-marked silicone hydrogel contact lenses for daily wear use

Also known as: PV2, PureVision® 2

PV2 contact lenses

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Investigators will enroll charts following a pre-identified process.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (1)

Contact Alcon Call Center for Trial Locations

Fort Worth, Texas, 76134, United States

Location

MeSH Terms

Conditions

Refractive Errors; Myopia; Hyperopia

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

• Clinical Trial Lead, CRD Vision Care

  Alcon Research, LLC

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2023
• First Posted: August 4, 2023
• Study Start: October 3, 2023
• Primary Completion: July 30, 2024
• Study Completion: July 30, 2024
• Last Updated: August 9, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)