AONDA Therapeutic Indication Study I
1 other identifier
observational
55
1 country
3
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jun 2023
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 24, 2023
CompletedFirst Posted
Study publicly available on registry
June 6, 2023
CompletedStudy Start
First participant enrolled
June 28, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 10, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 10, 2023
CompletedJuly 20, 2023
July 1, 2023
12 days
May 24, 2023
July 18, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Baseline, Follow-Up Visit (up to 1 year following the Baseline Visit)
Study Arms (1)
AONDA Therapeutic
Lotrafilcon A contact lenses worn therapeutically as a bandage lens as instructed by the eye care professional
Interventions
CE-marked silicone hydrogel contact lenses
Eligibility Criteria
Investigators will enroll charts following a pre-identified process.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alcon Researchlead
Study Sites (3)
Vision Health Institute
Orlando, Florida, 32803, United States
Franklin Park Eye Center PC
Franklin Park, Illinois, 60131, United States
Optometry Group, PLLC
Memphis, Tennessee, 38111, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trial Lead, CRD Vision Care
Alcon Research, LLC
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 24, 2023
First Posted
June 6, 2023
Study Start
June 28, 2023
Primary Completion
July 10, 2023
Study Completion
July 10, 2023
Last Updated
July 20, 2023
Record last verified: 2023-07
Data Sharing
- IPD Sharing
- Will not share