Air Optix Extended Wear Contact Lenses
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Air Optix Aqua Sphere Lotrafilcon B spherical soft contact lenses worn in both eyes on an extended wear basis. Extended wear is defined as up to 6 days continuous wear (including while sleeping/overnight). |
Device: Lotrafilcon B spherical soft contact lenses
Commercially available silicone hydrogel contact lenses
Other Names:
|
| Air Optix plus HydraGlyde Sphere Lotrafilcon B multifocal soft contact lenses with comfort additive worn in both eyes on an extended wear basis. Extended wear is defined as up to 6 days continuous wear (including while sleeping/overnight). |
Device: Lotrafilcon B spherical soft contact lenses with comfort additive
Commercially available silicone hydrogel contact lenses
Other Names:
|
| Air Optix plus HydraGlyde Toric Lotrafilcon B toric soft contact lenses with comfort additive worn in both eyes on an extended wear basis. Extended wear is defined as up to 6 days continuous wear (including while sleeping/overnight). |
Device: Lotrafilcon B toric soft contact lenses with comfort additive
Commercially available silicone hydrogel contact lenses
Other Names:
|
| Biofinity Sphere Comfilcon A spherical soft contact lenses worn in both eyes on an extended wear basis. Extended wear is defined as up to 6 days continuous wear (including while sleeping/overnight). |
Device: Comfilcon A spherical soft contact lenses
Commercially available silicone hydrogel contact lenses
Other Names:
|
| Biofinity Toric Comfilcon A toric soft contact lenses worn in both eyes on an extended wear basis. Extended wear is defined as up to 6 days continuous wear (including while sleeping/overnight). |
Device: Comfilcon A toric soft contact lenses
Commercially available silicone hydrogel contact lenses
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Distance visual acuity (VA) with study lenses at Baseline [Baseline (Day 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. Baseline 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Manifest refraction cylinder less than or equal to 0.75 diopter (D) in each eye at baseline (sphere wearers only);
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Best corrected visual acuity (BCVA) of 20/25 Snellen or better in each eye at baseline;
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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;
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Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
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Any recurrent history or active anterior segment infection, inflammation or abnormality contraindicating regular contact lens wear at baseline;
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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;
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Other protocol-defined exclusion criteria may apply.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Alcon Research
Investigators
- Study Director: Clinical Trial Lead, Vision Care, Alcon Research, LLC
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CLJ241-N002