Air Optix Extended Wear Contact Lenses

Refractive Errors Clinical Trial

Official title:

Air Optix Extended Wear Contact Lenses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05886881
• Other study ID #: CLJ241-N002
• Status: Completed
• Start date: August 3, 2023
• Est. completion date: May 6, 2024

Study information

• Verified date: March 2024
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this Post-Market Clinical Follow-Up (PMCF) study is to assess long term performance and safety of Air Optix Aqua Sphere, Air Optix plus HydraGlyde Sphere, and Air Optix plus HydraGlyde Toric soft contact lenses in a real-world setting when worn as extended (overnight) wear.

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, e.g., reviewing all eligible charts in reverse chronological order by year of baseline visit. Subjects/charts meeting the eligibility criteria will be enrolled in the study. The data collection period is defined as any approximately 1-year to 3-year timeframe since the respective lens brand was prescribed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 484
• Est. completion date: May 6, 2024
• Est. primary completion date: May 6, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Manifest refraction cylinder less than or equal to 0.75 diopter (D) in each eye at baseline (sphere wearers only);

• Best corrected visual acuity (BCVA) of 20/25 Snellen or better in each eye at baseline;

• Must have worn or be wearing Air Optix Aqua Sphere, Air Optix plus HydraGlyde Sphere, Air Optix plus HydraGlyde Toric, Biofinity Sphere or Biofinity Toric for at least 3 years in an extended wear modality, as determined by the Investigator;

• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Any recurrent history or active anterior segment infection, inflammation or abnormality contraindicating regular contact lens wear at baseline;

• Use of systemic or ocular medications contraindicating regular contact lens wear at baseline and/or during the period of the retrospective chart collection;

• Slit lamp findings, including signs of pathological dry eye, that would contraindicate regular contact lens wear;

• Other protocol-defined exclusion criteria may apply.

Related Conditions & MeSH terms

• Refractive Errors

Intervention

Device:
• Lotrafilcon B spherical soft contact lenses
Commercially available silicone hydrogel contact lenses
• Lotrafilcon B spherical soft contact lenses with comfort additive
Commercially available silicone hydrogel contact lenses
• Lotrafilcon B toric soft contact lenses with comfort additive
Commercially available silicone hydrogel contact lenses
• Comfilcon A spherical soft contact lenses
Commercially available silicone hydrogel contact lenses
• Comfilcon A toric soft contact lenses
Commercially available silicone hydrogel contact lenses

Locations

Country	Name	City	State
United States	Complete Eye Care of Medina	Medina	Minnesota
United States	Vision Health Institute	Orlando	Florida
United States	Koetting Associates	Saint Louis	Missouri
United States	Smith Bowman Ophthalmology	Salt Lake City	Utah

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 (VA) with study lenses at Year 1	The subject's chart will be reviewed for distance visual acuity at Year 1, defined as a visit which occurred 1 year (-2/+4 months) since baseline during which period the subject was wearing either the study or comparator lenses and a contact lens examination was performed. The Baseline visit is defined as the first office visit where an eye care practitioner provided an in-person office biomicroscopy exam to the patient before or during which a contact lens prescription for the study or comparator contact lens (lotrafilcon B or comfilcon A) was released.	Year 1
Primary	Distance visual acuity (VA) with study lenses at Year 3	The subject's chart will be reviewed for distance visual acuity at Year 3, defined as a visit which occurred 3 years (-2/+8 months) since baseline during which period the subject was wearing the protocol required contact lenses and a contact lens examination was performed.	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 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 exam.	Up to Year 3