Refractive Errors
Conditions
Keywords
Contact Lenses
Brief summary
The purpose of this Post-Market Clinical Follow-Up (PMCF) study is to assess long term performance and safety of Air Optix Aqua Sphere, Air Optix plus HydraGlyde Sphere, and Air Optix plus HydraGlyde Toric soft contact lenses in a real-world setting when worn as extended (overnight) wear.
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, e.g., reviewing all eligible charts in reverse chronological order by year of baseline visit. Subjects/charts meeting the eligibility criteria will be enrolled in the study. The data collection period is defined as any approximately 1-year to 3-year timeframe since the respective lens brand was prescribed.
Interventions
Commercially available silicone hydrogel contact lenses
Commercially available silicone hydrogel contact lenses
Commercially available silicone hydrogel contact lenses
Commercially available silicone hydrogel contact lenses
Commercially available silicone hydrogel contact lenses
Sponsors
Alcon Research
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Manifest refraction cylinder less than or equal to 0.75 diopter (D) in each eye at baseline (sphere wearers only); * Best corrected visual acuity (BCVA) of 20/25 Snellen or better in each eye at baseline; * Must have worn or be wearing Air Optix Aqua Sphere, Air Optix plus HydraGlyde Sphere, Air Optix plus HydraGlyde Toric, Biofinity Sphere or Biofinity Toric for at least 3 years in an extended wear modality, as determined by the Investigator; * Other protocol-defined inclusion criteria may apply.
Exclusion criteria
* Any recurrent history or active anterior segment infection, inflammation or abnormality contraindicating regular contact lens wear at baseline; * Use of systemic or ocular medications contraindicating regular contact lens wear at baseline and/or during the period of the retrospective chart collection; * Slit lamp findings, including signs of pathological dry eye, that would contraindicate regular contact lens wear; * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Distance visual acuity (VA) with study lenses at Year 1 | Year 1 | The subject's chart will be reviewed for distance visual acuity at Year 1, defined as a visit which occurred 1 year (-2/+4 months) since baseline during which period the subject was wearing either the study or comparator lenses and a contact lens examination was performed. The Baseline visit is defined as the first office visit where an eye care practitioner provided an in-person office biomicroscopy exam to the patient before or during which a contact lens prescription for the study or comparator contact lens (lotrafilcon B or comfilcon A) was released. |
| Distance visual acuity (VA) with study lenses at Year 3 | Year 3 | The subject's chart will be reviewed for distance visual acuity at Year 3, defined as a visit which occurred 3 years (-2/+8 months) since baseline during which period the subject was wearing the protocol required contact lenses and a contact lens examination was performed. |
| 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 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 exam. |
Countries
United States
Outcome results
None listed