Clinical Assessment of DAILIES TOTAL1® (DT1) Multifocal

Study Overview
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Brief Summary
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The purpose of this study is to evaluate DAILIES TOTAL1® Multifocal (DTl MF) contact lenses in current multifocal contact lens wearers with symptoms of end of day discomfort compared to their habitual multifocal contact lens correction.

Official Title
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DAILIES TOTAL1® Multifocal Clinical Assessment in Challenging Patients

Conditions
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Refractive Error

Intervention / Treatment
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* Device: Delefilcon A multifocal contact lenses
* Device: Habitual multifocal contact lenses


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must sign an informed consent document; Current daily wearer of soft multifocal contact lenses for at least 6 months with symptoms of contact lens discomfort as defined by the prescreening Eligibility Questionnaire; Requires a near spectacle add of +0.50 to +2.50 diopters (D) (inclusive); Requires lenses within the power range of study lenses to be fitted; Best corrected VA (BCVA) of 20/30 (0.2 logarithmic minimum angle of resolution [logMAR]) or better in each eye at distance; Willing to wear study lenses for a minimum of 5 days per week, 6 hours per day, and attend all study visits; Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Any eye condition that contraindicates wearing contact lenses as determined by the Investigator; Any use of medications for which contact lens wear could be contraindicated, as determined by the Investigator; Monocular (only one eye functional) or fit with only 1 lens; Fitted with monovision; Prior refractive surgery (e.g., laser vision correction, photorefractive keratectomy, etc.); History of herpetic keratitis, ocular surgery, or irregular cornea; Currently wearing DT1 MF contact lenses; Other protocol-defined exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: DT1 MF, then Habitual<br>Delefilcon A multifocal contact lenses in Period 1, followed by subject's habitual multifocal contact lenses in Period 2. Each product worn bilaterally (in both eyes) for 14 ± 3 days. | Device: Delefilcon A multifocal contact lenses<br>* Multifocal contact lenses worn in a daily wear, daily disposable modality (new pair of lenses each morning)<br>* Other names: DAILIES TOTAL1® multifocal;Device: Habitual multifocal contact lenses<br>* Multifocal contact lenses worn per subject's habitual prescription and habitual daily wear modality<br>|
| Other: Habitual, then DT1 MF<br>Subject's habitual multifocal contact lenses in Period 1, followed by delefilcon A multifocal contact lenses in Period 2. Each product worn bilaterally (in both eyes) for 14 ± 3 days. | Device: Delefilcon A multifocal contact lenses<br>* Multifocal contact lenses worn in a daily wear, daily disposable modality (new pair of lenses each morning)<br>* Other names: DAILIES TOTAL1® multifocal;Device: Habitual multifocal contact lenses<br>* Multifocal contact lenses worn per subject's habitual prescription and habitual daily wear modality<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Binocular High Contrast/High Illumination (HC/HI) Visual Acuity (VA) at Intermediate Distance (80 cm) | Visual Acuity (clarity or sharpness of vision) was measured at high contrast level. HC/HI VA was assessed binocularly (both eyes together) at 80 centimeters using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart and measured in logarithm of the minimum angle of resolution (logMAR). A lower logMAR value indicates better visual acuity. | Day 14, each product | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) Score | The abbreviated CLDEQ-8 is an 8-item questionnaire used to assess comfort and dryness. Total CLDEQ-8 score ranged from 0 to 37, where a lower score represented less symptomology. | Day 14, each product | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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myopia, presbyopia