An observational study in Bullous Keratopathy, Corneal Erosion and Entropion, sponsored by Alcon Research. Completed at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-07-20.
Sponsored by Alcon Research (part of Alcon) · Observational
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.
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.
39 studies on the registry are indexed under Corneal Edema; 8 are open to participants now.
Browse Corneal Edema studies →Alcon Research is the lead sponsor of 624 studies on the registry; 9 are open to participants now.
Of its 112 completed or terminated interventional studies of FDA-regulated products, 102 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Investigators will enroll charts following a pre-identified process.
Key Inclusion Criteria:
Key Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Lotrafilcon A contact lenses worn therapeutically as a bandage lens as instructed by the eye care professional
Device: Lotrafilcon A contact lenses
CE-marked silicone hydrogel contact lenses
Also known as: AONDA, AIR OPTIX® NIGHT & DAY® AQUA
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.
Time frame: Baseline, Follow-Up Visit (up to 1 year following the Baseline Visit)
Plan to share: No
No publications or documents are linked to this record.
Ran from Jun 2023 to primary completion in Jul 2023, 0 months.
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This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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