An observational study in Refractive Errors, Myopia and Hyperopia, sponsored by Alcon Research. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-09.
Sponsored by Alcon Research (part of Alcon) · Observational
Among 96 studies in Refractive Errors by Alcon Research — none open to participants now, none under way, none of them phase 3. Refractive Errors · Alcon Research.
Among the 96 studies in Refractive Errors by Alcon Research, this one is one of 11 that started in 2023, is one of 7 observational ones, and was the 88th registered.
420 studies on the registry are indexed under Refractive Errors; 59 are open to participants now.
Browse Refractive Errors studies →None of the 96 studies in Refractive Errors by Alcon Research is open now.
Of the 30 Refractive Errors studies recruiting now, 8 (27%) set no upper age limit and 19 (63%) stop at 75 or younger; 16 take children under 18; 18 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
96 studies; the count open now beside each. This study's row is marked.
First in 2008; this study’s year is marked. 11 started in 2023.
This study's enrollment of 102 is below the median of 150 across 108 observational studies indexed under Refractive Errors.
Median enrollment 69 across the 89 interventional studies, 312 across the 7 observational. Of the 95 that completed or were terminated, 81 (85%) have results posted.
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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.
None of the studies under way reaches primary completion within a year.
Among the 96 studies in Refractive Errors by Alcon Research, from their registry updates:
Nothing recorded among them since 2026-09-25.
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The purpose of this Post-Market Clinical Follow-Up (PMCF) study is to assess long term performance and safety of Air Optix® Night and Day® Aqua (AONDA) contact lenses in a real-world setting when worn as daily wear for vision correction.
This is a non-interventional/observational study designed as a retrospective chart review. Study sites will review charts within their existing database to identify subjects who wore AONDA contact lenses or PureVision® 2 (PV2) contact lenses in both eyes for approximately 1 year following their contact lens examination. The data collection period consists of any approximately 1-year timeframe since and including 2009.
The anticipated duration of the study is approximately 6 months.
Investigators will enroll charts following a pre-identified process.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria
Lotrafilcon A contact lenses worn daily and removed at night for cleaning and disinfection as instructed by the eye care professional
Device: Lotrafilcon A contact lenses
Balafilcon A contact lenses worn daily and removed at night for cleaning and disinfection as instructed by the eye care professional
Device: Balafilcon A contact lenses
CE-marked silicone hydrogel contact lenses for daily wear use
Also known as: AONDA, Air Optix® Night and Day® Aqua
CE-marked silicone hydrogel contact lenses for daily wear use
Also known as: PV2, PureVision® 2
Distance visual acuity by eye
The subject's chart will be reviewed for distance visual acuity.
Time frame: Year 1
Incidence of corneal infiltrative events
The subject's chart will be reviewed for incidences of corneal infiltrative events occurring after the baseline exam.
Time frame: Up to Year 1
Incidence of microbial keratitis
The subject's chart will be reviewed for incidences of microbial keratitis occurring after the baseline exam.
Time frame: Up to Year 1
Plan to share: No
No publications or documents are linked to this record.
Ran from Oct 2023 to primary completion in Jul 2024, 9 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.