Refractive ErrorsNCT05992675
Air Optix® Night and Day® Aqua Continuous Wear
An observational study of Refractive Errors, run by Alcon Research at 8 sites in United States.
Trial summary
The purpose of this retrospective, Post-Market Clinical Follow-Up (PMCF) study is to assess the long term performance and safety of Air Optix® Night and Day® Aqua (AONDA) contact lenses in a real-world setting when worn as 30 days of continuous 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
- What is being tested?
- Lotrafilcon A contact lenses and Balafilcon A contact lenses
- Type of treatment
- Medical device
- How many people
- 1,256 participants
- Where
- 8 sitesUnited States
- Study dates
- 5 Oct 2023to 22 Aug 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
- Manifest refraction cylinder less than or equal to 0.75 diopter in each eye at baseline
- Best corrected visual acuity of 20/25 or better in each eye at baseline
- At the time of Year 3 Visit, subject was prescribed and wearing AONDA or PV2 contact lenses in both eyes in a 30-day continuous wear modality for at least approximately 3 years
- Baseline Visit and Year 3 Visit charts available
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
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Pearle Vision
Jacksonville, Florida, 32246
Complete Eye Care of Medina
Medina, Minnesota, 55340
Jackson Health Community Center
Miami, Florida, 33126
Vision Health Institute
Orlando, Florida, 32803
Smith Bowman Ophthalmology
Salt Lake City, Utah, 84117
Complete Family Vision Care
San Diego, California, 92123
Koetting Associates
St Louis, Missouri, 63144
Sacco Eye Group
Vestal, New York, 13850
About this study
The purpose of this retrospective, Post-Market Clinical Follow-Up (PMCF) study is to assess the long term performance and safety of Air Optix® Night and Day® Aqua (AONDA) contact lenses in a real-world setting when worn as 30 days of continuous wear for vision correction.
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. Subjects/charts meeting the eligibility criteria will be enrolled in the study.
The study is designed with one period. The duration of the period includes the Baseline Visit and the Year 3 Visit as follows:
- The Baseline Visit is defined as the first office visit where an eye care professional provided an in-person office biomicroscopy exam to the subject, before or during which a contact lens prescription for AONDA or PureVision 2 (PV2) was released.
- The Year 3 Visit is defined as a visit which occurred 3 years (-2/+8 months) since Baseline during which period the subject was wearing AONDA contact lenses or PV2 contact lenses and a contact lens examination was performed.
The data collection period is defined as any approximately 3-year timeframe since and including 2009.
- Conditions
- Refractive Errors
- Being tested
- Lotrafilcon A contact lenses, Balafilcon A contact lenses
- Keywords
- Contact Lenses, Overnight wear
- 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 A contact lensesDevice
Also called Air Optix® Night and Day® Aqua, AONDA
CE-marked silicone hydrogel contact lenses
Balafilcon A contact lensesDevice
Also called PureVision® 2, PV2
CE-marked silicone hydrogel contact lenses
| Study group | Role | What they receive |
|---|---|---|
| AONDA contact lenses | Lotrafilcon A contact lenses worn in a 30-day, continuous wear modality (lenses worn continuously including overnight) over a period of approximately 3 years Receives: Device: Lotrafilcon A contact lenses | |
| PV2 contact lenses | Balafilcon A contact lenses worn in a 30-day, continuous wear modality (lenses worn continuously including overnight) over a period of approximately 3 years 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
The subject's chart will be reviewed for distance visual acuity.
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 Visit 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 Visit 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 posted15 Aug 2023
- Study start5 Oct 2023
- Primary completion22 Aug 2024
- Study completion22 Aug 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
- 1,256 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
- NCT05992675
- Sponsor's protocol ID
- CLD265-N003
- Status last verified
- Sep 2024
- First submitted
- 8 Aug 2023
- Last updated
- 19 Sep 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 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Air Optix® Night and Day® Aqua Continuous Wear
- ClinicalTrials.gov ID
- NCT05992675
- Acronym / sponsor ID
- CLD265-N003
- Conditions
- Refractive Errors
- Keywords
- Contact Lenses, Overnight wear
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,256 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- 5 Oct 2023 (actual)
- Primary completion
- 22 Aug 2024 (actual)
- Study completion
- 22 Aug 2024 (actual)
- First posted
- 15 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 retrospective, Post-Market Clinical Follow-Up (PMCF) study is to assess the long term performance and safety of Air Optix® Night and Day® Aqua (AONDA) contact lenses in a real-world setting when worn as 30 days of continuous wear for vision correction.
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. Subjects/charts meeting the eligibility criteria will be enrolled in the study.
The study is designed with one period. The duration of the period includes the Baseline Visit and the Year 3 Visit as follows:
- The Baseline Visit is defined as the first office visit where an eye care professional provided an in-person office biomicroscopy exam to the subject, before or during which a contact lens prescription for AONDA or PureVision 2 (PV2) was released.
- The Year 3 Visit is defined as a visit which occurred 3 years (-2/+8 months) since Baseline during which period the subject was wearing AONDA contact lenses or PV2 contact lenses and a contact lens examination was performed.
The data collection period is defined as any approximately 3-year timeframe since and including 2009.
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 in a 30-day, continuous wear modality (lenses worn continuously including overnight) over a period of approximately 3 years |
| PV2 contact lenses | – | Device: Balafilcon A contact lensesBalafilcon A contact lenses worn in a 30-day, continuous wear modality (lenses worn continuously including overnight) over a period of approximately 3 years |
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 in each eye at baseline
- Best corrected visual acuity of 20/25 or better in each eye at baseline
- At the time of Year 3 Visit, subject was prescribed and wearing AONDA or PV2 contact lenses in both eyes in a 30-day continuous wear modality for at least approximately 3 years
- Baseline Visit and Year 3 Visit charts available
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
- 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
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: Air Optix® Night and Day® Aqua, AONDACE-marked silicone hydrogel contact lenses | Device | AONDA contact lenses |
| Balafilcon A contact lensesAlso: PureVision® 2, PV2CE-marked silicone hydrogel contact lenses | Device | PV2 contact lenses |
Primary outcome
Distance visual acuity
Time frame: Year 3
The subject's chart will be reviewed for distance visual acuity.
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 Visit 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 Visit 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 19 Sep 2024.
- 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, CRD Vision Care study director
Alcon Research, LLC
8 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 8 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 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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 (time frame: Year 3). 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 19 Sep 2024.