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NCT05976750 Clinical Trial

Air Optix® Night and Day® Aqua Daily Wear

Myopia Clinical Trial

Official title:
Air Optix® Night and Day® Aqua Daily Wear

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT05976750
Other study ID # CLD265-N002
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date October 3, 2023
Est. completion date May 2024

Study information
Verified date April 2024
Source Alcon Research
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 110
Est. completion date May 2024
Est. primary completion date May 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Normal eyes, as determined by the Investigator - At the time of the 1-year visit, subject was prescribed and wearing AONDA contact lenses or PV2 contact lenses in both eyes in a daily wear modality for at least approximately 1 year without changing wear modality - Baseline and 1-year visit charts available - Other protocol-specified inclusion criteria may apply Exclusion Criteria - Any recurrent history or active anterior segment infection, inflammation, abnormality, or disease contraindicating regular contact lens wear present at Baseline - Use of systemic or ocular medications contraindicating regular contact lens wear at Baseline - History of refractive surgery or irregular cornea - Other protocol-specified exclusion criteria may apply

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Lotrafilcon A contact lenses
CE-marked silicone hydrogel contact lenses for daily wear use
• Balafilcon A contact lenses
CE-marked silicone hydrogel contact lenses for daily wear use

Locations
Country Name City State
United States Contact Alcon Call Center for Trial Locations Fort Worth Texas

Sponsors (1)
Lead Sponsor Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Distance visual acuity by eye The subject's chart will be reviewed for distance visual acuity. Year 1
Primary Incidence of corneal infiltrative events The subject's chart will be reviewed for incidences of corneal infiltrative events occurring after the baseline exam. Up to Year 1
Primary Incidence of microbial keratitis The subject's chart will be reviewed for incidences of microbial keratitis occurring after the baseline exam. Up to Year 1
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