Bullous KeratopathyNCT05891106
AONDA Therapeutic Indication Study I
An observational study of Bullous Keratopathy and Corneal Erosion, run by Alcon Research at 3 sites in United States.
Trial summary
This study will be used to support assessment of AIR OPTIX® NIGHT \& DAY® AQUA (AONDA) Soft Contact Lenses' safety and performance in accordance with updated European Union Medical Device Regulation (EU 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
- Type of treatment
- Medical device
- How many people
- 55 participants
- Where
- 3 sitesUnited States
- Study dates
- 28 Jun 2023to 10 Jul 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
- 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 Soft Contact Lens as a therapeutic contact lens was placed on one or both eye(s) 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 contact lens wear or confounds study results during the data collection period, as determined or known by the Investigator.
- Used systemic or ocular medication that would confound study results during the data collection period, as determined or known by the Investigator.
- Other protocol-defined exclusion criteria may apply.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Franklin Park Eye Center PC
Franklin Park, Illinois, 60131
Optometry Group, PLLC
Memphis, Tennessee, 38111
Vision Health Institute
Orlando, Florida, 32803
About this study
This study will be used to support assessment of AIR OPTIX® NIGHT \& DAY® AQUA (AONDA) Soft Contact Lenses' safety and performance in accordance with updated European Union Medical Device Regulation (EU MDR) requirements.
Read the detailed description
In this retrospective observational study, the subject wore AONDA as a therapeutic lens for the treatment of a corneal condition with pain in one or both eyes.
- Conditions
- Bullous Keratopathy, Corneal Erosion, Entropion, Corneal Edema, Corneal Dystrophy, Corneal Ulcer
- Being tested
- Lotrafilcon A contact lenses
- Medical subject headings
- Entropion, Corneal Edema, Corneal Dystrophies, Hereditary, Corneal Ulcer, Bell Palsy, Keratoconjunctivitis, Sjogren's Syndrome
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 & DAY® AQUA
CE-marked silicone hydrogel contact lenses
| Study group | Role | What they receive |
|---|---|---|
| AONDA Therapeutic | Lotrafilcon A contact lenses worn therapeutically as a bandage lens as instructed by the eye care professional Receives: Device: Lotrafilcon 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
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 AONDA therapeutic contact lens was placed on eye as part of a treatment plan for an ocular condition. The Follow-up Visit is defined as the first visit where the AONDA 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.
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 posted6 Jun 2023
- Study start28 Jun 2023
- Primary completion10 Jul 2023
- Study completion10 Jul 2023
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.
- 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
- 55 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
- NCT05891106
- Sponsor's protocol ID
- CLD265-P002
- Status last verified
- Jul 2023
- First submitted
- 24 May 2023
- Last updated
- 20 Jul 2023
- 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 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AONDA Therapeutic Indication Study I
- ClinicalTrials.gov ID
- NCT05891106
- Acronym / sponsor ID
- CLD265-P002
- Conditions
- Bullous Keratopathy, Corneal Erosion, Entropion, Corneal Edema, Corneal Dystrophy, Corneal Ulcer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- 28 Jun 2023 (actual)
- Primary completion
- 10 Jul 2023 (actual)
- Study completion
- 10 Jul 2023 (actual)
- First posted
- 6 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.
This study will be used to support assessment of AIR OPTIX® NIGHT \& DAY® AQUA (AONDA) Soft Contact Lenses' safety and performance in accordance with updated European Union Medical Device Regulation (EU MDR) requirements.
Detailed description
In this retrospective observational study, the subject wore AONDA as a therapeutic lens for the treatment of a corneal condition with pain in one or both eyes.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AONDA Therapeutic | – | Device: Lotrafilcon A contact lensesLotrafilcon A contact lenses worn therapeutically as a bandage lens 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 Soft Contact Lens as a therapeutic contact lens was placed on one or both eye(s) 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 contact lens wear or confounds study results during the data collection period, as determined or known by the Investigator.
- Used systemic or ocular medication that would confound study results during the data collection period, as determined or known by the Investigator.
- 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: AONDA, AIR OPTIX® NIGHT & DAY® AQUACE-marked silicone hydrogel contact lenses | Device | AONDA Therapeutic |
Primary outcome
Change from baseline in corneal pain at the Follow-up Visit
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 AONDA therapeutic contact lens was placed on eye as part of a treatment plan for an ocular condition. The Follow-up Visit is defined as the first visit where the AONDA 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.
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 20 Jul 2023.
- 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 20 Jul 2023. 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 (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 20 Jul 2023; AzTrials last refreshed its copy on 27 Oct 2026.