Initial Performance of a Daily Disposable Contact Lens Featuring Molded Marks

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the impact of back surface molded marks (MM) applied to delefilcon A contact lenses as measured by the incidence of ocular discomfort device-related adverse events with DAILIES TOTAL1® Multifocal contact lenses with molded marks (DT1 MF MM) and current DAILIES TOTAL1® Multifocal contact lenses (DT1 MF).

Official Title
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Initial Performance of a Daily Disposable Contact Lens Featuring Molded Marks

Conditions
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Refractive Error

Intervention / Treatment
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* Device: Delefilcon A Multifocal Contact Lenses with Molded Mark
* Device: Delefilcon A Multifocal Contact Lenses


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must sign an Informed Consent document; Current wearer of commercial DAILIES TOTAL1® contact lenses; Have spectacles in current prescription available to be worn in conjunction with the investigational product; Manifest astigmatism less than or equal to 0.75 diopter (D) (at screening) Best corrected distance visual acuity (BCVA) greater than or equal to 20/25 in each eye; Other protocol-specified inclusion criteria may apply. Exclusion Criteria: Eye injury in either eye within 12 weeks prior to study enrollment; Any anterior segment infection, inflammation, disease, or abnormality that contraindicates contact lens wear; Any use of systemic or ocular medications for which contact lens wear could be contraindicated; History of herpetic keratitis, refractive surgery or irregular cornea; A pathologically dry eye that precludes contact lens wear; Concurrent participation in a contact lens or contact lens care product clinical trial within the previous 30 days; Monocular (only 1 eye with functional vision); Other protocol-specified exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 18 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: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DT1 MF MM<br>Delefilcon A multifocal contact lenses with molded marks on back surface worn bilaterally (in both eyes) for 9 hours | Device: Delefilcon A Multifocal Contact Lenses with Molded Mark<br> <br> |
| Active Comparator: DT1 MF<br>Delefilcon A multifocal contact lenses worn bilaterally for 9 hours | Device: Delefilcon A Multifocal Contact Lenses<br> <br> * Other names: DAILIES TOTAL1® Multifocal (DT1 MF);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Ocular Discomfort Device-related Adverse Events (AE) | An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device (test article). Ocular discomfort device-related AE was defined as an ocular AE classified as Related to study device and deemed to be related to ocular discomfort. | Day 1 at Hour 9 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular Staining | Assessed by the Investigator through slit-lamp examination and graded on a 5-point scale, where 0=none and 4=severe. Ocular staining was categorized by corneal staining, conjunctival staining, and limbal staining. Both eyes contributed to the analysis. | Day 1 at Hour 9 | 
| Limbal Hyperemia | Hyperemia (excess of blood) was assessed by the Investigator through slit-lamp examination and graded on a 5-point scale, where 0=none and 4=severe. Both eyes contributed to the analysis. | Day 1 at Hour 9 |