Air Optix® Night and Day® Aqua Continuous Wear
- Conditions
- Refractive Errors
- Interventions
- Device: Lotrafilcon A contact lensesDevice: Balafilcon A contact lenses
- Registration Number
- NCT05992675
- Lead Sponsor
- Alcon Research
- Brief Summary
The purpose of this retrospective, Post-Market Clinical Follow-Up (PMCF) study is to assess the long term performance and safety of Air Optix® Night and Day® Aqua (AONDA) contact lenses in a real-world setting when worn as 30 days of continuous wear for vision correction.
- Detailed Description
This is a non-interventional/observational study designed as a retrospective chart review. Study sites will identify charts within their existing databases in a fair and consistent manner. Subjects/charts meeting the eligibility criteria will be enrolled in the study.
The study is designed with one period. The duration of the period includes the Baseline Visit and the Year 3 Visit as follows:
* The Baseline Visit is defined as the first office visit where an eye care professional provided an in-person office biomicroscopy exam to the subject, before or during which a contact lens prescription for AONDA or PureVision 2 (PV2) was released.
* The Year 3 Visit is defined as a visit which occurred 3 years (-2/+8 months) since Baseline during which period the subject was wearing AONDA contact lenses or PV2 contact lenses and a contact lens examination was performed.
The data collection period is defined as any approximately 3-year timeframe since and including 2009.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 1140
- Manifest refraction cylinder less than or equal to 0.75 diopter in each eye at baseline
- Best corrected visual acuity of 20/25 or better in each eye at baseline
- At the time of Year 3 Visit, subject was prescribed and wearing AONDA or PV2 contact lenses in both eyes in a 30-day continuous wear modality for at least approximately 3 years
- Baseline Visit and Year 3 Visit charts available
Key
- Any recurrent history or active anterior segment infection, inflammation, abnormality, or disease contraindicating regular contact lens wear present at baseline
- The use of systemic or ocular medications contraindicating regular contact lens wear at baseline
- History of refractive surgery or irregular cornea
- Slit lamp findings, including signs of pathological dry eye, that would contraindicate regular contact lens wear at baseline
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description AONDA contact lenses Lotrafilcon A contact lenses Lotrafilcon A contact lenses worn in a 30-day, continuous wear modality (lenses worn continuously including overnight) over a period of approximately 3 years PV2 contact lenses Balafilcon A contact lenses Balafilcon A contact lenses worn in a 30-day, continuous wear modality (lenses worn continuously including overnight) over a period of approximately 3 years
- Primary Outcome Measures
Name Time Method Distance visual acuity Year 3 The subject's chart will be reviewed for distance visual acuity.
Incidence of corneal infiltrative events Up to Year 3 The subject's chart will be reviewed for incidences of corneal infiltrative events occurring after the Baseline Visit exam.
Incidence of microbial keratitis Up to Year 3 The subject's chart will be reviewed for incidences of microbial keratitis occurring after the Baseline Visit exam.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (8)
Complete Eye Care of Medina
🇺🇸Medina, Minnesota, United States
Vision Health Institute
🇺🇸Orlando, Florida, United States
Sacco Eye Group
🇺🇸Vestal, New York, United States
Koetting Associates
🇺🇸Saint Louis, Missouri, United States
Smith Bowman Ophthalmology
🇺🇸Salt Lake City, Utah, United States
Complete Family Vision Care
🇺🇸San Diego, California, United States
Jackson Health Community Center
🇺🇸Miami, Florida, United States
Pearle Vision
🇺🇸Jacksonville, Florida, United States