Air Optix® Night and Day® Aqua Continuous Wear

Refractive Errors Clinical Trial

Official title:

Air Optix® Night and Day® Aqua Continuous Wear

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05992675
• Other study ID #: CLD265-N003
• Status: Enrolling by invitation
• Start date: October 5, 2023
• Est. completion date: July 2024

Study information

• Verified date: November 2023
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

This is a non-interventional/observational study designed as a retrospective chart review. Study sites will identify charts within their existing databases in a fair and consistent manner. Subjects/charts meeting the eligibility criteria will be enrolled in the study.

The study is designed with one period. The duration of the period includes the Baseline Visit and the Year 3 Visit as follows:

• The Baseline Visit is defined as the first office visit where an eye care professional provided an in-person office biomicroscopy exam to the subject, before or during which a contact lens prescription for AONDA or PureVision 2 (PV2) was released.

• The Year 3 Visit is defined as a visit which occurred 3 years (-2/+8 months) since Baseline during which period the subject was wearing AONDA contact lenses or PV2 contact lenses and a contact lens examination was performed.

The data collection period is defined as any approximately 3-year timeframe since and including 2009.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 1140
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria:

• 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

Key Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Refractive Errors

Intervention

Device:
• Lotrafilcon A contact lenses
CE-marked silicone hydrogel contact lenses
• Balafilcon A contact lenses
CE-marked silicone hydrogel contact lenses

Locations

Country	Name	City	State
United States	Pearle Vision	Jacksonville	Florida
United States	Complete Eye Care of Medina	Medina	Minnesota
United States	Jackson Health Community Center	Miami	Florida
United States	Vision Health Institute	Orlando	Florida
United States	Koetting Associates	Saint Louis	Missouri
United States	Smith Bowman Ophthalmology	Salt Lake City	Utah
United States	Complete Family Vision Care	San Diego	California
United States	Sacco Eye Group	Vestal	New York

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Distance visual acuity	The subject's chart will be reviewed for distance visual acuity.	Year 3
Primary	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
Primary	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