Astigmatism, Hyperopia, Myopia, Presbyopia
Conditions
Keywords
Contact lenses
Brief summary
The purpose of this study is to continuously assess the visual performance and safety of DAILIES TOTAL1 soft contact lenses in a real world setting and broader patient base through routine clinical practices. This activity will be used to continuously support delefilcon A (sphere, toric, and multifocal) soft contact lens regulatory requirements and standards.
Detailed description
This study includes a Baseline visit and a Year 1 visit. 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 DAILIES TOTAL1 sphere, toric, or multifocal soft contact lens prescription was released. The Baseline visit will be retrospective. All assessments at baseline will be obtained from chart reviews. The Year 1 visit is defined as the visit that occurs 1 year (-2/+4 months) since the Baseline visit during which period the subject is wearing prescribed lenses and a contact lens examination is performed. The Year 1 visit can be either retrospective or prospective in subjects 7 to less than 18 years of age. For subjects 18 years of age and older, the Year 1 visit will be retrospective.
Interventions
DEVICEDelefilcon A spherical soft contact lenses
Silicone hydrogel contact lenses prescribed for single use, daily disposable wear (less than 24 hours while awake) for the correction of ametropia (myopia or hyperopia)
DEVICEDelefilcon A toric soft contact lenses
Silicone hydrogel contact lenses prescribed for single use, daily disposable wear (less than 24 hours while awake) for the correction of ametropia (myopia or hyperopia) with astigmatism
DEVICEDelefilcon A multifocal soft contact lenses
Silicone hydrogel contact lenses prescribed for single use, daily disposable wear (less than 24 hours while awake) for the correction of ametropia (myopia or hyperopia) with presbyopia
Sponsors
Alcon Research
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
7 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * At baseline: 7 years of age or older for sphere and toric wearers, 40 years of age or older for multifocal wearers. * Wearers of delefilcon A (sphere, toric, or multifocal) soft contact lenses of the same design in both eyes who have already begun use of the lens type and have purchased at least 3-month supply of lenses at baseline. * Best corrected distance visual acuity (BCVA) 20/25 or better in each eye at baseline. * Other protocol-defined inclusion criteria may apply. Key
Exclusion criteria
* Any ocular disease or condition that would contraindicate contact lens wear at baseline. * Use of systemic or ocular medications that would contraindicate contact lens wear at baseline. * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Distance visual acuity (VA) with study lenses at Baseline - Sphere and Toric | Baseline | Distance VA will be assessed for each eye individually with study lenses in place and recorded in Snellen. This endpoint is prespecified for DAILIES TOTAL1 spherical contact lenses and DAILIES TOTAL1 for Astigmatism contact lenses. |
| Distance visual acuity with study lenses at Year 1 Follow-up - Sphere and Toric | Year 1 Follow-Up | Distance VA will be assessed for each eye individually with study lenses in place and recorded in Snellen. This endpoint is prespecified for DAILIES TOTAL1 spherical contact lenses and DAILIES TOTAL1 for Astigmatism contact lenses. |
| Distance visual acuity with study lenses at Baseline - Multifocal | Baseline | Distance visual acuity will be assessed for both eyes together with study lenses in place and recorded in Snellen. This endpoint is prespecified for DAILIES TOTAL1 multifocal contact lenses. |
| Distance visual acuity with study lenses at Year 1 Follow-Up - Multifocal | Year 1 Follow-Up | Distance visual acuity will be assessed for both eyes together with study lenses in place and recorded in Snellen. This endpoint is prespecified for DAILIES TOTAL1 multifocal contact lenses. |
| Near visual acuity with study lenses at Baseline - Multifocal | Baseline | Near visual acuity will be assessed for both eyes together with study lenses in place and recorded in Snellen. This endpoint is prespecified for DAILIES TOTAL1 multifocal contact lenses. |
| Near visual acuity with study lenses at Year 1 Follow-Up - Multifocal | Year 1 Follow-Up | Near visual acuity will be assessed for both eyes together with study lenses in place and recorded in Snellen. This endpoint is prespecified for DAILIES TOTAL1 multifocal contact lenses. |
| Incidence of corneal infiltrative events | Up to Year 1 | A corneal infiltrate is a single or group of inflammatory cells in the normally clear cornea. |
| Incidence of microbial keratitis | Up to Year 1 | Microbial keratitis is a sight-threatening infection of the cornea. |
Countries
United States
Outcome results
None listed