Refractive ErrorsNCT05827224

Air Optix Daily Wear Contact Lenses

An observational study of Refractive Errors, run by Alcon Research at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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, Air Optix plus HydraGlyde Sphere, and Air Optix plus HydraGlyde Toric soft contact lenses in a real-world setting when worn as daily wear. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Refractive Errors
What is being tested?: Lotrafilcon B spherical soft contact lenses, Lotrafilcon B spherical soft contact lenses with comfort additive and Lotrafilcon B toric soft contact lenses with comfort additive
Type of treatment: Medical device
How many people: 312 participants
Where: 5 sitesUnited States
Study dates: 2 Aug 2023to 17 Jul 2024
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Adult, Older adult

Study population: Investigators will enroll charts following a pre-identified process.

Who may be able to join

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 1 year in a daily wear modality, as determined by the Investigator;
Other protocol-defined inclusion criteria may apply.

Who cannot join

Have worn or be wearing Air Optix Aqua Sphere, Air Optix plus HydraGlyde Sphere, Air Optix plus HydraGlyde Toric, Biofinity Sphere, or Biofinity Toric contact lenses in an extended wear modality;
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.

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 sites

Complete Eye Care of Medina
Medina, Minnesota, 55340
Toyos Clinic
Nashville, Tennessee, 37215
Vision Health Institute
Orlando, Florida, 32803
Smith Bowman Ophthalmology
Salt Lake City, Utah, 84117
Koetting Associates
St Louis, Missouri, 63144

Other trials in United States

About this study

Read the detailed 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. The baseline visit will be 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 lenses was released. Subjects meeting the eligibility criteria will be enrolled in the study.

Conditions: Refractive Errors
Being tested: Lotrafilcon B spherical soft contact lenses, Lotrafilcon B spherical soft contact lenses with comfort additive, Lotrafilcon B toric soft contact lenses with comfort additive, Comfilcon A spherical soft contact lenses, Comfilcon A toric soft contact lenses
Keywords: Contact Lenses
Medical subject headings: Refractive Errors

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Lotrafilcon B spherical soft contact lensesDevice
Also called Air Optix® Aqua Sphere
Commercially available silicone hydrogel contact lenses
Lotrafilcon B spherical soft contact lenses with comfort additiveDevice
Also called Air Optix® plus HydraGlyde® Sphere
Commercially available silicone hydrogel contact lenses
Lotrafilcon B toric soft contact lenses with comfort additiveDevice
Also called Air Optix® plus HydraGlyde® Toric
Commercially available silicone hydrogel contact lenses
Comfilcon A spherical soft contact lensesDevice
Also called Biofinity Sphere
Commercially available silicone hydrogel contact lenses
Comfilcon A toric soft contact lensesDevice
Also called Biofinity Toric
Commercially available silicone hydrogel contact lenses

Study groups in NCT05827224
Study group	Role	What they receive
Air Optix Aqua Sphere		Lotrafilcon B spherical soft contact lenses worn in both eyes and removed daily for cleaning and disinfection Receives: Device: Lotrafilcon B spherical soft contact lenses
Air Optix plus HydraGlyde Sphere		Lotrafilcon B spherical soft contact lenses with comfort additive worn in both eyes and removed daily for cleaning and disinfection Receives: 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 and removed daily for cleaning and disinfection Receives: Device: Lotrafilcon B toric soft contact lenses with comfort additive
Biofinity Sphere		Comfilcon A spherical soft contact lenses worn in both eyes and removed daily for cleaning and disinfection Receives: Device: Comfilcon A spherical soft contact lenses
Biofinity Toric		Comfilcon A toric soft contact lenses worn in both eyes and removed daily for cleaning and disinfection Receives: Device: Comfilcon A toric soft contact lenses

What is being measured

The primary outcome is the main question the study is designed to answer.

Distance visual acuity (VA) with study lenses
The subject's chart will be reviewed for distance visual acuity at baseline and at 1 year following the baseline exam.
Measured: Up to 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.
Measured: 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.
Measured: Up to Year 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Aug 202317 Jul 2024

First posted24 Apr 2023
Study start2 Aug 2023
Primary completion17 Jul 2024
Study completion17 Jul 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Refractive ErrorsStudies of the same condition, open and under way.
More trials run by Alcon ResearchThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Retrospective
Enrolment: 312 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05827224
Sponsor's protocol ID: CLJ241-N001
Status last verified: Aug 2024
First submitted: 13 Apr 2023
Last updated: 15 Aug 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Managing Premyopia in Chinese Children Using Artificial Intelligence Assisted Defocus Incorporated Multiple Segments Based Spectacle Lens: a Randomized Controlled Clinical Trial
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BRIGHT-LIGHT: Studying Red Light Therapy for Severe Short-Sightedness or Short-Sightedness That Worsens Despite Standard Treatment
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Clinical Performance and Outcomes After Toric Lens Transition
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RecruitingPhase 1/2
Psilocybin for Amblyopia - Targeting Critical Periods in Humans
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Recruiting
Evaluation of a New Laser Refractive Vision Correction Using the TENEO™ 317 Model 2
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All Refractive Errors trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Air Optix Daily Wear Contact Lenses
ClinicalTrials.gov ID: NCT05827224
Acronym / sponsor ID: CLJ241-N001
Conditions: Refractive Errors
Keywords: Contact Lenses
Study type: Observational
Recruitment status: Completed
Enrolment: 312 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: 2 Aug 2023 (actual)
Primary completion: 17 Jul 2024 (actual)
Study completion: 17 Jul 2024 (actual)
First posted: 24 Apr 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 5

Arm	Type	Receives
Air Optix Aqua Sphere	–	Device: Lotrafilcon B spherical soft contact lensesLotrafilcon B spherical soft contact lenses worn in both eyes and removed daily for cleaning and disinfection
Air Optix plus HydraGlyde Sphere	–	Device: Lotrafilcon B spherical soft contact lenses with comfort additiveLotrafilcon B spherical soft contact lenses with comfort additive worn in both eyes and removed daily for cleaning and disinfection
Air Optix plus HydraGlyde Toric	–	Device: Lotrafilcon B toric soft contact lenses with comfort additiveLotrafilcon B toric soft contact lenses with comfort additive worn in both eyes and removed daily for cleaning and disinfection
Biofinity Sphere	–	Device: Comfilcon A spherical soft contact lensesComfilcon A spherical soft contact lenses worn in both eyes and removed daily for cleaning and disinfection
Biofinity Toric	–	Device: Comfilcon A toric soft contact lensesComfilcon A toric soft contact lenses worn in both eyes and removed daily for cleaning and disinfection

Who may qualify

Ages: 18 years and older
Sex: All
Age groups: Adult, Older adult
Study population: Investigators will enroll charts following a pre-identified process.

Key inclusion criteria (4 listed)

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 1 year in a daily wear modality, as determined by the Investigator;
Other protocol-defined inclusion criteria may apply.

Key exclusion criteria (5 listed)

Have worn or be wearing Air Optix Aqua Sphere, Air Optix plus HydraGlyde Sphere, Air Optix plus HydraGlyde Toric, Biofinity Sphere, or Biofinity Toric contact lenses in an extended wear modality;
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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Lotrafilcon B spherical soft contact lensesAlso: Air Optix® Aqua SphereCommercially available silicone hydrogel contact lenses	Device	Air Optix Aqua Sphere
Lotrafilcon B spherical soft contact lenses with comfort additiveAlso: Air Optix® plus HydraGlyde® SphereCommercially available silicone hydrogel contact lenses	Device	Air Optix plus HydraGlyde Sphere
Lotrafilcon B toric soft contact lenses with comfort additiveAlso: Air Optix® plus HydraGlyde® ToricCommercially available silicone hydrogel contact lenses	Device	Air Optix plus HydraGlyde Toric
Comfilcon A spherical soft contact lensesAlso: Biofinity SphereCommercially available silicone hydrogel contact lenses	Device	Biofinity Sphere
Comfilcon A toric soft contact lensesAlso: Biofinity ToricCommercially available silicone hydrogel contact lenses	Device	Biofinity Toric

Primary outcome

Distance visual acuity (VA) with study lenses
Time frame: Up to Year 1
The subject's chart will be reviewed for distance visual acuity at baseline and at 1 year following the baseline exam.
Incidence of corneal infiltrative events
Time frame: Up to Year 1
The subject's chart will be reviewed for incidences of corneal infiltrative events occurring after the baseline exam.
Incidence of microbial keratitis
Time frame: Up to Year 1
The subject's chart will be reviewed for incidences of microbial keratitis occurring after the baseline exam.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2024.
Individual participant dataSharing planned: No

Related trials for Refractive Errors

Recruiting
Managing Premyopia in Chinese Children Using Artificial Intelligence Assisted Defocus Incorporated Multiple Segments Based Spectacle Lens: a Randomized Controlled Clinical Trial
Pre-myopia, Myopia
Not yet recruiting
BRIGHT-LIGHT: Studying Red Light Therapy for Severe Short-Sightedness or Short-Sightedness That Worsens Despite Standard Treatment
Myopia, Myopia Progressing
Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
RecruitingPhase 1/2
Psilocybin for Amblyopia - Targeting Critical Periods in Humans
Amblyopia
Recruiting
Evaluation of a New Laser Refractive Vision Correction Using the TENEO™ 317 Model 2
Hyperopia and Myopia

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Clinical Trial Lead, Vision Care study director

Alcon Research, LLC

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Refractive Errors, run by Alcon Research at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Distance visual acuity (VA) with study lenses (time frame: Up to Year 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05827224.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2024.