Air Optix® Night and Day® Aqua Continuous Wear

NCT05992675 | Completed FDA Device

• 1 other identifier: CLD265-N003
• Study Type: observational
• Target: 1,256
• Locations: 1 country
• Sites: 8

Brief Summary

The purpose of this retrospective, Post-Market Clinical Follow-Up (PMCF) study is to assess the long term performance and safety of Air Optix® Night and Day® Aqua (AONDA) contact lenses in a real-world setting when worn as 30 days of continuous wear for vision correction.

Conditions

Refractive Errors

Keywords

Contact Lenses; Overnight wear

Outcome Measures

Primary Outcomes (3)

• Distance visual acuity

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

  Year 3

• Incidence of corneal infiltrative events

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

  Up to Year 3

• Incidence of microbial keratitis

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

  Up to Year 3

Study Arms (2)

AONDA contact lenses

Lotrafilcon A contact lenses worn in a 30-day, continuous wear modality (lenses worn continuously including overnight) over a period of approximately 3 years

Device: Lotrafilcon A contact lenses

PV2 contact lenses

Balafilcon A contact lenses worn in a 30-day, continuous wear modality (lenses worn continuously including overnight) over a period of approximately 3 years

Device: Balafilcon A contact lenses

Interventions

Lotrafilcon A contact lenses DEVICE

CE-marked silicone hydrogel contact lenses

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

AONDA contact lenses

Balafilcon A contact lenses DEVICE

CE-marked silicone hydrogel contact lenses

Also known as: PureVision® 2, PV2

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:

• Manifest refraction cylinder less than or equal to 0.75 diopter in each eye at baseline
• Best corrected visual acuity of 20/25 or better in each eye at baseline
• At the time of Year 3 Visit, subject was prescribed and wearing AONDA or PV2 contact lenses in both eyes in a 30-day continuous wear modality for at least approximately 3 years
• Baseline Visit and Year 3 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
• 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

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (8)

Complete Family Vision Care

San Diego, California, 92123, United States

Location

Pearle Vision

Jacksonville, Florida, 32246, United States

Location

Jackson Health Community Center

Miami, Florida, 33126, United States

Location

Vision Health Institute

Orlando, Florida, 32803, United States

Location

Complete Eye Care of Medina

Medina, Minnesota, 55340, United States

Location

Koetting Associates

St Louis, Missouri, 63144, United States

Location

Sacco Eye Group

Vestal, New York, 13850, United States

Location

Smith Bowman Ophthalmology

Salt Lake City, Utah, 84117, United States

Location

MeSH Terms

Conditions

Refractive Errors

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: August 8, 2023
• First Posted: August 15, 2023
• Study Start: October 5, 2023
• Primary Completion: August 22, 2024
• Study Completion: August 22, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)