Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

505

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Aug 2023

Geographic Reach

1 country

4 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.7 years study duration

First Submitted

Initial submission to the registry

May 24, 2023

Completed

9 days until next milestone

First Posted

Study publicly available on registry

June 2, 2023

Completed

2 months until next milestone

Study Start

First participant enrolled

August 3, 2023

Completed

1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2025

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2025

Completed

Last Updated

August 14, 2025

Status Verified

August 1, 2025

Enrollment Period

1.7 years

First QC Date

May 24, 2023

Last Update Submit

August 12, 2025

Conditions

Refractive Errors

Keywords

Contact Lenses

Outcome Measures

Primary Outcomes (4)

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
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
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
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

Study Arms (5)

Air Optix Aqua Sphere

Lotrafilcon B spherical soft contact lenses worn in both eyes on an extended wear basis. Extended wear is defined as up to 6 days continuous wear (including while sleeping/overnight).

Device: Lotrafilcon B spherical soft contact lenses

Air Optix plus HydraGlyde Sphere

Lotrafilcon B multifocal soft contact lenses with comfort additive worn in both eyes on an extended wear basis. Extended wear is defined as up to 6 days continuous wear (including while sleeping/overnight).

Device: Lotrafilcon B spherical soft contact lenses with comfort additive

Air Optix plus HydraGlyde Toric

Lotrafilcon B toric soft contact lenses with comfort additive worn in both eyes on an extended wear basis. Extended wear is defined as up to 6 days continuous wear (including while sleeping/overnight).

Device: Lotrafilcon B toric soft contact lenses with comfort additive

Biofinity Sphere

Comfilcon A spherical soft contact lenses worn in both eyes on an extended wear basis. Extended wear is defined as up to 6 days continuous wear (including while sleeping/overnight).

Device: Comfilcon A spherical soft contact lenses

Biofinity Toric

Comfilcon A toric soft contact lenses worn in both eyes on an extended wear basis. Extended wear is defined as up to 6 days continuous wear (including while sleeping/overnight).

Device: Comfilcon A toric soft contact lenses