Refractive AmetropiaNCT05790928

Air Optix Night and Day Aqua (AONDA) Retrospective Study 1

An observational study of Refractive Ametropia and Hyperopia, run by Alcon Research at 4 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 study is to assess long term performance and safety of AONDA in a real world setting when worn as daily wear or continuous wear for vision correction. This study will be used to support AONDA's marketability in Europe and other locations. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Refractive Ametropia, Hyperopia, Myopia
What is being tested?: Lotrafilcon A spherical contact lenses
Type of treatment: Medical device
How many people: 108 participants
Where: 4 sitesUnited States
Study dates: 25 Mar 2023to 31 Mar 2023
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

Normal eyes, as determined or known by the investigator;
Manifest refraction cylinder less than or equal to 0.75 diopter (D) in each eye at baseline;
Best Corrected Visual Acuity (BCVA) of 20/25 Snellen or better in each eye at baseline;
At the time of the 1-year visit, subject was prescribed and wearing AONDA in both eyes in either a DW or CW modality for at least approximately 1 without changing modality;
Baseline and 1-year visit chart available;
Other protocol-specified inclusion criteria may apply.

Who cannot join

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;
Other protocol-specified exclusion criteria may apply.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

The Eye Doctors Inc
Eden Prairie, Minnesota, 55344
Franklin Park Eye Center PC
Franklin Park, Illinois, 60131
Optometry Group, PLLC
Memphis, Tennessee, 38111
Tallahassee Eye Center
Tallahassee, Florida, 32308

Other trials in United States

About this study

Official title: AONDA Retrospective Study 1

Read the detailed description

In this retrospective observational study, the subject used AONDA for at least approximately 1 year in either a daily wear (DW) or continuous wear (CW) modality with monthly replacement. For the CW cohort only, 3-year data will be collected, if available.

Conditions: Refractive Ametropia, Hyperopia, Myopia
Being tested: Lotrafilcon A spherical contact lenses
Medical subject headings: Hyperopia, Myopia

What participants receive

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

Lotrafilcon A spherical contact lensesDevice
Also called AIR OPTIX Night & Day AQUA, AONDA
CE-marked silicone hydrogel contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia) in persons with minimal astigmatism that does not interfere with visual acuity

Study groups in NCT05790928
Study group	Role	What they receive
AONDA DW		Lotrafilcon A contact lenses worn in a daily wear (DW) modality (lenses removed nightly for cleaning) for at least 1 year with monthly replacement. Receives: Device: Lotrafilcon A spherical contact lenses
AONDA CW		Lotrafilcon A contact lenses worn in a continuous wear (CW) modality (lenses worn continuously including overnight) for at least 1 year with monthly replacement. Receives: Device: Lotrafilcon A spherical contact lenses

What is being measured

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

Distance visual acuity at Year 1 - DW Cohort
The subject's chart will be reviewed for a distance visual acuity assessment at 1 year after the baseline exam. The 1-year visit will be defined as a visit which occurred 1 year (-2/+4 months) since baseline, during which period the subject was wearing AONDA, and a contact lens examination was performed. Baseline will be defined as the first office visit where the investigator provided an in-person office biomicroscopy exam to the patient, before or during which a contact lens prescription for AONDA was released.
Measured: Year 1
Distance Visual Acuity at Year 1 - CW Cohort
The subject's chart will be reviewed for a distance visual acuity assessment at 1 year after the baseline exam. The 1-year visit will be defined as a visit which occurred 1 year (-2/+4 months) since baseline, during which period the subject was wearing AONDA, and a contact lens examination was performed. Baseline will be defined as the first office visit where the investigator provided an in-person office biomicroscopy exam to the patient, before or during which a contact lens prescription for AONDA was released.
Measured: Year 1
Distance Visual Acuity at Year 3 - CW Cohort
The subject's chart will be reviewed for a distance visual acuity assessment at 3 years after the baseline exam. The 3-year visit will be defined as a visit which occurred 3 years (-2/+8 months) since baseline, during which period the subject was wearing AONDA and a contact lens examination was performed. The 3-year visit will be applicable only if the chart indicates the subject was wearing AONDA since baseline and 1-year.
Measured: Year 3
Incidence of Corneal Infiltrative Events up to Year 1 - DW Cohort
The subject's chart will be reviewed for corneal infiltrative adverse events occurring after the baseline exam. Baseline will be defined as the first office visit where the investigator provided an in-person office biomicroscopy exam to the patient, before or during which a contact lens prescription for AONDA was released.
Measured: Up to Year 1
Incidence of Corneal Infiltrative Events up to Year 1 - CW Cohort
The subject's chart will be reviewed for corneal infiltrative adverse events occurring after the baseline exam. Baseline will be defined as the first office visit where the investigator provided an in-person office biomicroscopy exam to the patient, before or during which a contact lens prescription for AONDA was released.
Measured: Up to Year 1
Incidence of Corneal Infiltrative Events Up to Year 3 - CW Cohort
The subject's chart will be reviewed for corneal infiltrative adverse events occurring after the baseline exam. Baseline will be defined as the first office visit where the investigator provided an in-person office biomicroscopy exam to the patient, before or during which a contact lens prescription for AONDA was released.
Measured: Up to Year 3
Incidence of Microbial Keratitis up to Year 1 - DW Cohort
The subject's chart will be reviewed for incidences of microbial keratitis occurring after the baseline exam. Baseline will be defined as the first office visit where the investigator provided an in-person office biomicroscopy exam to the patient, before or during which a contact lens prescription for AONDA was released.
Measured: Up to Year 1
Incidence of Microbial Keratitis up to Year 1 - CW Cohort
The subject's chart will be reviewed for incidences of microbial keratitis occurring after the baseline exam. Baseline will be defined as the first office visit where the investigator provided an in-person office biomicroscopy exam to the patient, before or during which a contact lens prescription for AONDA was released.
Measured: Up to Year 1
Incidence of Microbial Keratitis up to Year 3 - CW Cohort
The subject's chart will be reviewed for incidences of microbial keratitis occurring after the baseline exam. Baseline will be defined as the first office visit where the investigator provided an in-person office biomicroscopy exam to the patient, before or during which a contact lens prescription for AONDA was released.
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.

25 Mar 202331 Mar 2023

First posted30 Mar 2023
Study start25 Mar 2023
Primary completion31 Mar 2023
Study completion31 Mar 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Refractive AmetropiaStudies 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: 108 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05790928
Sponsor's protocol ID: CLD265-P001
Status last verified: May 2023
First submitted: 7 Mar 2023
Last updated: 25 May 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

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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All Refractive Ametropia trials

Study at a glance

From the registry record, last updated by the sponsor on 25 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: AONDA Retrospective Study 1
ClinicalTrials.gov ID: NCT05790928
Acronym / sponsor ID: CLD265-P001
Conditions: Refractive Ametropia, Hyperopia, Myopia
Study type: Observational
Recruitment status: Completed
Enrolment: 108 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: 25 Mar 2023 (actual)
Primary completion: 31 Mar 2023 (actual)
Study completion: 31 Mar 2023 (actual)
First posted: 30 Mar 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: 2

Arm	Type	Receives
AONDA DW	–	Device: Lotrafilcon A spherical contact lensesLotrafilcon A contact lenses worn in a daily wear (DW) modality (lenses removed nightly for cleaning) for at least 1 year with monthly replacement.
AONDA CW	–	Device: Lotrafilcon A spherical contact lensesLotrafilcon A contact lenses worn in a continuous wear (CW) modality (lenses worn continuously including overnight) for at least 1 year with monthly replacement.

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 (6 listed)

Normal eyes, as determined or known by the investigator;
Manifest refraction cylinder less than or equal to 0.75 diopter (D) in each eye at baseline;
Best Corrected Visual Acuity (BCVA) of 20/25 Snellen or better in each eye at baseline;
At the time of the 1-year visit, subject was prescribed and wearing AONDA in both eyes in either a DW or CW modality for at least approximately 1 without changing modality;
Baseline and 1-year visit chart available;

Key exclusion criteria (5 listed)

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;
Other protocol-specified 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 A spherical contact lensesAlso: AIR OPTIX Night & Day AQUA, AONDACE-marked silicone hydrogel contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia) in persons with minimal astigmatism that does not interfere with visual acuity	Device	AONDA CW, AONDA DW

Primary outcome

Distance visual acuity at Year 1 - DW Cohort
Time frame: Year 1
The subject's chart will be reviewed for a distance visual acuity assessment at 1 year after the baseline exam. The 1-year visit will be defined as a visit which occurred 1 year (-2/+4 months) since baseline, during which period the subject was wearing AONDA, and a contact lens examination was performed. Baseline will be defined as the first office visit where the investigator provided an in-person office biomicroscopy exam to the patient, before or during which a contact lens prescription for AONDA was released.
Distance Visual Acuity at Year 1 - CW Cohort
Time frame: Year 1
The subject's chart will be reviewed for a distance visual acuity assessment at 1 year after the baseline exam. The 1-year visit will be defined as a visit which occurred 1 year (-2/+4 months) since baseline, during which period the subject was wearing AONDA, and a contact lens examination was performed. Baseline will be defined as the first office visit where the investigator provided an in-person office biomicroscopy exam to the patient, before or during which a contact lens prescription for AONDA was released.
Distance Visual Acuity at Year 3 - CW Cohort
Time frame: Year 3
The subject's chart will be reviewed for a distance visual acuity assessment at 3 years after the baseline exam. The 3-year visit will be defined as a visit which occurred 3 years (-2/+8 months) since baseline, during which period the subject was wearing AONDA and a contact lens examination was performed. The 3-year visit will be applicable only if the chart indicates the subject was wearing AONDA since baseline and 1-year.
Incidence of Corneal Infiltrative Events up to Year 1 - DW Cohort
Time frame: Up to Year 1
The subject's chart will be reviewed for corneal infiltrative adverse events occurring after the baseline exam. Baseline will be defined as the first office visit where the investigator provided an in-person office biomicroscopy exam to the patient, before or during which a contact lens prescription for AONDA was released.
Incidence of Corneal Infiltrative Events up to Year 1 - CW Cohort
Time frame: Up to Year 1
The subject's chart will be reviewed for corneal infiltrative adverse events occurring after the baseline exam. Baseline will be defined as the first office visit where the investigator provided an in-person office biomicroscopy exam to the patient, before or during which a contact lens prescription for AONDA was released.
Incidence of Corneal Infiltrative Events Up to Year 3 - CW Cohort
Time frame: Up to Year 3
The subject's chart will be reviewed for corneal infiltrative adverse events occurring after the baseline exam. Baseline will be defined as the first office visit where the investigator provided an in-person office biomicroscopy exam to the patient, before or during which a contact lens prescription for AONDA was released.
Incidence of Microbial Keratitis up to Year 1 - DW Cohort
Time frame: Up to Year 1
The subject's chart will be reviewed for incidences of microbial keratitis occurring after the baseline exam. Baseline will be defined as the first office visit where the investigator provided an in-person office biomicroscopy exam to the patient, before or during which a contact lens prescription for AONDA was released.
Incidence of Microbial Keratitis up to Year 1 - CW Cohort
Time frame: Up to Year 1
The subject's chart will be reviewed for incidences of microbial keratitis occurring after the baseline exam. Baseline will be defined as the first office visit where the investigator provided an in-person office biomicroscopy exam to the patient, before or during which a contact lens prescription for AONDA was released.
Incidence of Microbial Keratitis up to Year 3 - CW Cohort
Time frame: Up to Year 3
The subject's chart will be reviewed for incidences of microbial keratitis occurring after the baseline exam. Baseline will be defined as the first office visit where the investigator provided an in-person office biomicroscopy exam to the patient, before or during which a contact lens prescription for AONDA was released.

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 25 May 2023.

Related trials for Refractive Ametropia

Active, not recruiting
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Not yet recruiting
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The Impact of 'A Miss Is as Good as a Mile': Is Compensation Necessary for Minimal Ocular Deviation in Myopic Laser Surgery?
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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, CRD 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 Ametropia and Hyperopia, 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 6 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 25 May 2023. 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 at Year 1 - DW Cohort (time frame: Year 1). The study lists 9 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 NCT05790928.

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 25 May 2023.