Status:
COMPLETED
Air Optix® Night and Day® Aqua Continuous Wear
Lead Sponsor:
Alcon Research
Conditions:
Refractive Errors
Eligibility:
All Genders
18+ years
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-worl...
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/ch...
Eligibility Criteria
Inclusion
- Key
- 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
Exclusion
- 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
Key Trial Info
Start Date :
October 5 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 22 2024
Estimated Enrollment :
1256 Patients enrolled
Trial Details
Trial ID
NCT05992675
Start Date
October 5 2023
End Date
August 22 2024
Last Update
September 19 2024
Active Locations (8)
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1
Complete Family Vision Care
San Diego, California, United States, 92123
2
Pearle Vision
Jacksonville, Florida, United States, 32246
3
Jackson Health Community Center
Miami, Florida, United States, 33126
4
Vision Health Institute
Orlando, Florida, United States, 32803