Evaluation of Soft Multifocal Lenses in Presbyopic Previous Contact Lens Wearers

Study Overview
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Brief Summary
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To explore the wear experience in Dailies TOTAL1 Multifocal contact lenses in presbyopic adults who have previously dropped out of contact lens wear.

Detailed Description
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The purpose of this study is to evaluate the wear experience of people with presbyopia who previously dropped out of contact lens wear when fit with a Delefilcon A soft lens multifocal lens. Investigators expect to enroll a relatively equal amount of former soft multifocal contact lens wearers who dropped out due to poor vision at distance or near and single vision wearers who dropped out due to poor near vision. The key endpoints include Visual Analog Scale survey of lens wear symptoms (comfort, dryness, vision) with contact lenses and assessment of the participant's quality of life with the Dailies TOTAL1 Multifocal® contact lenses.

Official Title
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Evaluation of Soft Multifocal Lenses in Presbyopic Previous Contact Lens Wearers

Conditions
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Presbyopia

Intervention / Treatment
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* Device: Daily disposable multifocal soft contact lens


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ability to give informed consent. Any gender. Any racial or ethnic origin. At least 38 years of age or older. Willing to spend time for the study. Three visits are required to complete the study, and additional follow up visits could be scheduled if needed. Subjects must have corrected distance visual acuity in both eyes equivalent to 20/25 or better at the screening visit. Spectacle sphere power range between +6.00 to -10.00. Previously dropped out of contact lens wear due to vision or vision and discomfort. Good general health (defined by medication use that has not changed within the last month and the absence of medical conditions or treatments that are deemed confounding to the data as determined by the PI Exclusion Criteria: Current or active ocular inflammation or infection as determined by the Investigator. Astigmatism ≥ 1.00 D in either eye. History of previous eye surgery. Strabismus or binocular vision abnormalities that prevent completion of testing, at the discretion of the Investigator. Demonstration or history of corneal ectasia or keratoconus. Pregnant or lactating

Ages Eligible for Study
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Minimum Age: 38 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lens wear experience<br>Subject will wear contact lenses for about a month during the day. | Device: Daily disposable multifocal soft contact lens<br>* Daily disposable multifocal soft contact lens that will be worn for 1 month.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scale | Visual Analog Scale survey of lens wear symptoms (comfort, dryness, vision) with contact lenses | 1 month | 
| Quality of Life Survey | Assessment of the participant's quality of life with the daily disposable multifocal contact lenses | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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contact lenses, Multifocal contact lenses