Refractive ErrorsNCT05886881
Air Optix Extended Wear Contact Lenses
An observational study of Refractive Errors, run by Alcon Research at 4 sites in United States.
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. 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
- 505 participants
- Where
- 4 sitesUnited States
- Study dates
- 3 Aug 2023to 15 Apr 2025
- 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
- No healthy volunteers
- 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 3 years in an extended wear modality, as determined by the Investigator;
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- 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
4 sites in 1 country.
United States4 sites
Complete Eye Care of Medina
Medina, Minnesota, 55340
Vision Health Institute
Orlando, Florida, 32803
Smith Bowman Ophthalmology
Salt Lake City, Utah, 84117
Koetting Associates
St Louis, Missouri, 63144
About this study
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.
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. 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.
- 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 group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). 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 on an extended wear basis. Extended wear is defined as up to 6 days continuous wear (including while sleeping/overnight). Receives: 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). Receives: 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). 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 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to Year 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2023
- Study start3 Aug 2023
- Primary completion15 Apr 2025
- Study completion15 Apr 2025
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
- 505 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Lead, Vision Care, Study director, Alcon Research, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05886881
- Sponsor's protocol ID
- CLJ241-N002
- Status last verified
- Aug 2025
- First submitted
- 24 May 2023
- Last updated
- 14 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Air Optix Extended Wear Contact Lenses
- ClinicalTrials.gov ID
- NCT05886881
- Acronym / sponsor ID
- CLJ241-N002
- Conditions
- Refractive Errors
- Keywords
- Contact Lenses
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 505 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- 3 Aug 2023 (actual)
- Primary completion
- 15 Apr 2025 (actual)
- Study completion
- 15 Apr 2025 (actual)
- First posted
- 2 Jun 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.
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.
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. 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.
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 on an extended wear basis. Extended wear is defined as up to 6 days continuous wear (including while sleeping/overnight). |
| Air Optix plus HydraGlyde Sphere | – | Device: Lotrafilcon B spherical soft contact lenses with comfort additiveLotrafilcon 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). |
| 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 on an extended wear basis. Extended wear is defined as up to 6 days continuous wear (including while sleeping/overnight). |
| Biofinity Sphere | – | Device: Comfilcon A spherical soft contact lensesComfilcon 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). |
| Biofinity Toric | – | Device: Comfilcon A toric soft contact lensesComfilcon 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- 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 3 years in an extended wear modality, as determined by the Investigator;
- Other protocol-defined inclusion criteria may apply.
Key exclusion criteria (4 listed)
- 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 at Year 1
Time frame: 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.
Distance visual acuity (VA) with study lenses at Year 3
Time frame: 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.
Incidence of corneal infiltrative events
Time frame: Up to Year 3
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 3
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 14 Aug 2025.
- Individual participant dataSharing planned: No
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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
4 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 4 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 4 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 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 at Year 1 (time frame: Year 1). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Aug 2025.