DAILIES TOTAL1® Soft Contact Lenses - Post-Market Clinical Follow-up Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

192 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-11-26

Study Completion Date

2025-02-27

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Myopia Hyperopia Presbyopia Astigmatism

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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DAILIES TOTAL1 Sphere

Delefilcon A spherical soft contact lenses worn in both eyes in a real-world setting

Delefilcon A spherical soft contact lenses

Intervention Type DEVICE

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)

DAILIES TOTAL1 Toric

Delefilcon A toric soft contact lenses worn in both eyes in a real-world setting

Delefilcon A toric soft contact lenses

Intervention Type DEVICE

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

DAILIES TOTAL1 Multifocal

Delefilcon A multifocal soft contact lenses worn in both eyes in a real-world setting

Delefilcon A multifocal soft contact lenses

Intervention Type DEVICE

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

Interventions

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Delefilcon 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)

Intervention Type DEVICE

Delefilcon 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

Intervention Type DEVICE

Delefilcon 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

Intervention Type DEVICE

Other Intervention Names

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DAILIES TOTAL1® Spherical Contact Lenses DAILIES TOTAL1® for Astigmatism Contact Lenses DAILIES TOTAL1® Multifocal Contact Lenses

Eligibility Criteria

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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.

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.

Minimum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No