Refractive ErrorsNCT05976750
Air Optix® Night and Day® Aqua Daily Wear
An observational study of Refractive Errors and Myopia, run by Alcon Research at 1 site 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® Night and Day® Aqua (AONDA) contact lenses in a real-world setting when worn as daily wear for vision correction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Refractive Errors, Myopia, Hyperopia
- What is being tested?
- Lotrafilcon A contact lenses and Balafilcon A contact lenses
- Type of treatment
- Medical device
- How many people
- 102 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Oct 2023to 30 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
- No healthy volunteers
- Adult, Older adult
Study population: Investigators will enroll charts following a pre-identified process.
Who may be able to join
- Normal eyes, as determined by the Investigator
- At the time of the 1-year visit, subject was prescribed and wearing AONDA contact lenses or PV2 contact lenses in both eyes in a daily wear modality for at least approximately 1 year without changing wear modality
- Baseline and 1-year visit charts 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
- Use of systemic or ocular medications contraindicating regular contact lens wear at Baseline
- History of refractive surgery or irregular cornea
- Other protocol-specified exclusion criteria may apply
Trial locations and contacts
1 site in 1 country.
United States1 site
Contact Alcon Call Center for Trial Locations
Fort Worth, Texas, 76134
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® Night and Day® Aqua (AONDA) contact lenses in a real-world setting when worn as daily wear for vision correction.
Read the detailed description
This is a non-interventional/observational study designed as a retrospective chart review. Study sites will review charts within their existing database to identify subjects who wore AONDA contact lenses or PureVision® 2 (PV2) contact lenses in both eyes for approximately 1 year following their contact lens examination. The data collection period consists of any approximately 1-year timeframe since and including 2009.
The anticipated duration of the study is approximately 6 months.
- Conditions
- Refractive Errors, Myopia, Hyperopia
- Being tested
- Lotrafilcon A contact lenses, Balafilcon A contact lenses
- Medical subject headings
- Refractive Errors, Myopia, Hyperopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lotrafilcon A contact lensesDevice
Also called AONDA, Air Optix® Night and Day® Aqua
CE-marked silicone hydrogel contact lenses for daily wear use
Balafilcon A contact lensesDevice
Also called PV2, PureVision® 2
CE-marked silicone hydrogel contact lenses for daily wear use
| Study group | Role | What they receive |
|---|---|---|
| AONDA contact lenses | Lotrafilcon A contact lenses worn daily and removed at night for cleaning and disinfection as instructed by the eye care professional Receives: Device: Lotrafilcon A contact lenses | |
| PV2 contact lenses | Balafilcon A contact lenses worn daily and removed at night for cleaning and disinfection as instructed by the eye care professional Receives: Device: Balafilcon A contact lenses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distance visual acuity by eye
The subject's chart will be reviewed for distance visual acuity.
Measured: 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.
- First posted4 Aug 2023
- Study start3 Oct 2023
- Primary completion30 Jul 2024
- Study completion30 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
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Lead, CRD Vision Care, Study director, Alcon Research, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05976750
- Sponsor's protocol ID
- CLD265-N002
- Status last verified
- Aug 2024
- First submitted
- 26 Jul 2023
- Last updated
- 9 Aug 2024
- 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 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Air Optix® Night and Day® Aqua Daily Wear
- ClinicalTrials.gov ID
- NCT05976750
- Acronym / sponsor ID
- CLD265-N002
- Conditions
- Refractive Errors, Myopia, Hyperopia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- 3 Oct 2023 (actual)
- Primary completion
- 30 Jul 2024 (actual)
- Study completion
- 30 Jul 2024 (actual)
- First posted
- 4 Aug 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® Night and Day® Aqua (AONDA) contact lenses in a real-world setting when worn as daily wear for vision correction.
Detailed description
This is a non-interventional/observational study designed as a retrospective chart review. Study sites will review charts within their existing database to identify subjects who wore AONDA contact lenses or PureVision® 2 (PV2) contact lenses in both eyes for approximately 1 year following their contact lens examination. The data collection period consists of any approximately 1-year timeframe since and including 2009.
The anticipated duration of the study is approximately 6 months.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AONDA contact lenses | – | Device: Lotrafilcon A contact lensesLotrafilcon A contact lenses worn daily and removed at night for cleaning and disinfection as instructed by the eye care professional |
| PV2 contact lenses | – | Device: Balafilcon A contact lensesBalafilcon A contact lenses worn daily and removed at night for cleaning and disinfection as instructed by the eye care professional |
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)
- Normal eyes, as determined by the Investigator
- At the time of the 1-year visit, subject was prescribed and wearing AONDA contact lenses or PV2 contact lenses in both eyes in a daily wear modality for at least approximately 1 year without changing wear modality
- Baseline and 1-year visit charts available
- Other protocol-specified inclusion criteria may apply
Key exclusion criteria (4 listed)
- Any recurrent history or active anterior segment infection, inflammation, abnormality, or disease contraindicating regular contact lens wear present at Baseline
- Use of systemic or ocular medications contraindicating regular contact lens wear at Baseline
- History of refractive surgery or irregular cornea
- 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 contact lensesAlso: AONDA, Air Optix® Night and Day® AquaCE-marked silicone hydrogel contact lenses for daily wear use | Device | AONDA contact lenses |
| Balafilcon A contact lensesAlso: PV2, PureVision® 2CE-marked silicone hydrogel contact lenses for daily wear use | Device | PV2 contact lenses |
Primary outcome
Distance visual acuity by eye
Time frame: Year 1
The subject's chart will be reviewed for distance visual acuity.
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 9 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, CRD Vision Care study director
Alcon Research, LLC
1 site 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 and Myopia, run by Alcon Research at 1 site 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 9 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 1 site 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 by eye (time frame: 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?
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 9 Aug 2024.