Bullous KeratopathyNCT05956535
Air Optix® Night and Day® Aqua Therapeutic Wear
An observational study of Bullous Keratopathy and Corneal Erosion, run by Alcon Research at 3 sites in United States.
Trial summary
The purpose of this study is to support the safety and performance assessment of Air Optix Night and Day Aqua (AONDA) soft contact lenses for therapeutic use in accordance with updated EU Medical Device Regulation (MDR) requirements. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bullous Keratopathy, Corneal Erosion, Entropion
- What is being tested?
- Lotrafilcon A contact lenses and Balafilcon A contact lenses
- Type of treatment
- Medical device
- How many people
- 168 participants
- Where
- 3 sitesUnited States
- Study dates
- 26 Sep 2023to 25 Oct 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
- Diagnosis of a corneal condition with pain for which AONDA or PV2 contact lenses were placed on one or both eye(s) as a therapeutic contact lens at Baseline.
- Baseline and Follow-up (up to 1 year from Baseline) charts available.
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- Had a condition (pathological, behavioral, and/or situational) that contraindicated therapeutic CL wear or confounds study results during the data collection period.
- Used systemic or ocular medication that would confound study results during the data collection period.
- Other protocol-defined exclusion criteria may apply.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Delray Physician Care Center
Delray Beach, Florida, 33445
Contact Alcon Call Center For Trial Locations
Fort Worth, Texas, 76134
Koetting Associates
St Louis, Missouri, 63144
About this study
The purpose of this study is to support the safety and performance assessment of Air Optix Night and Day Aqua (AONDA) soft contact lenses for therapeutic use in accordance with updated EU Medical Device Regulation (MDR) requirements.
Read the detailed description
In this retrospective, real world evidence study, the subjects wore Air Optix Night and Day Aqua (AONDA) soft contact lenses or PureVision 2 (PV2) soft contact lenses as a therapeutic lens for the treatment of a corneal condition with pain in one or both eyes as part of their eye care professional's treatment and management plan.
- Being tested
- Lotrafilcon A contact lenses, Balafilcon A contact lenses
- Keywords
- Bandage lens
- Medical subject headings
- Entropion, Corneal Edema, Corneal Dystrophies, Hereditary
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 therapeutically as a bandage lens in a continuous wear (CW) modality (lenses worn continuously including overnight) as instructed by the eye care professional. Receives: Device: Lotrafilcon A contact lenses | |
| PV2 contact lenses | Balafilcon A contact lenses worn therapeutically as a bandage lens in a continuous wear (CW) modality (lenses worn continuously including overnight) 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.
Change from baseline in corneal pain at the Follow-up Visit - Primary exposure
The Investigator will review the subject's chart and document change from baseline in corneal pain at the Follow-up visit as "improved, similar, or worsened." The Baseline Visit is defined as the first visit where the therapeutic contact lens was placed on eye as part of a treatment plan for a corneal condition. The Follow-up Visit is defined as the first visit where the therapeutic contact lens was removed from the eye, or the first visit following the removal of the contact lens if, for example, the contact lens was removed between visits. The primary exposure is defined as the first exposure to the study lens if, for example, there were multiple exposures to the study lens. The data collection period consists of any timeframe since and including 2009.
Measured: Baseline, Follow-up Visit (up to 1 year following the Baseline Visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2023
- Study start26 Sep 2023
- Primary completion25 Oct 2024
- Study completion25 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bullous KeratopathyStudies 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
- 168 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
- NCT05956535
- Sponsor's protocol ID
- CLD265-N001
- Status last verified
- Nov 2024
- First submitted
- 14 Jul 2023
- Last updated
- 13 Nov 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 13 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Air Optix® Night and Day® Aqua Therapeutic Wear
- ClinicalTrials.gov ID
- NCT05956535
- Acronym / sponsor ID
- CLD265-N001
- Keywords
- Bandage lens
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- 26 Sep 2023 (actual)
- Primary completion
- 25 Oct 2024 (actual)
- Study completion
- 25 Oct 2024 (actual)
- First posted
- 21 Jul 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 study is to support the safety and performance assessment of Air Optix Night and Day Aqua (AONDA) soft contact lenses for therapeutic use in accordance with updated EU Medical Device Regulation (MDR) requirements.
Detailed description
In this retrospective, real world evidence study, the subjects wore Air Optix Night and Day Aqua (AONDA) soft contact lenses or PureVision 2 (PV2) soft contact lenses as a therapeutic lens for the treatment of a corneal condition with pain in one or both eyes as part of their eye care professional's treatment and management plan.
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 therapeutically as a bandage lens in a continuous wear (CW) modality (lenses worn continuously including overnight) as instructed by the eye care professional. |
| PV2 contact lenses | – | Device: Balafilcon A contact lensesBalafilcon A contact lenses worn therapeutically as a bandage lens in a continuous wear (CW) modality (lenses worn continuously including overnight) 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 (3 listed)
- Diagnosis of a corneal condition with pain for which AONDA or PV2 contact lenses were placed on one or both eye(s) as a therapeutic contact lens at Baseline.
- Baseline and Follow-up (up to 1 year from Baseline) charts available.
- Other protocol-defined inclusion criteria may apply.
Key exclusion criteria (3 listed)
- Had a condition (pathological, behavioral, and/or situational) that contraindicated therapeutic CL wear or confounds study results during the data collection period.
- Used systemic or ocular medication that would confound study results during the data collection period.
- 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 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
Change from baseline in corneal pain at the Follow-up Visit - Primary exposure
Time frame: Baseline, Follow-up Visit (up to 1 year following the Baseline Visit)
The Investigator will review the subject's chart and document change from baseline in corneal pain at the Follow-up visit as "improved, similar, or worsened." The Baseline Visit is defined as the first visit where the therapeutic contact lens was placed on eye as part of a treatment plan for a corneal condition. The Follow-up Visit is defined as the first visit where the therapeutic contact lens was removed from the eye, or the first visit following the removal of the contact lens if, for example, the contact lens was removed between visits. The primary exposure is defined as the first exposure to the study lens if, for example, there were multiple exposures to the study lens. The data collection period consists of any timeframe since and including 2009.
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 13 Nov 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
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bullous Keratopathy and Corneal Erosion, run by Alcon Research at 3 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 3 inclusion and 3 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 13 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Change from baseline in corneal pain at the Follow-up Visit - Primary exposure (time frame: Baseline, Follow-up Visit (up to 1 year following the Baseline Visit)). 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 13 Nov 2024.