Initial Performance of a Modified Daily Disposable Contact Lens

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the incidence of ocular discomfort device-related adverse events with DAILIES TOTAL1® with UV Absorber (DT1 UV) contact lenses compared with current DAILIES TOTAL1® (DT1) contact lenses.

Official Title
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Initial Performance of a Modified Daily Disposable Silicone Hydrogel Contact Lens

Conditions
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Refractive Error

Intervention / Treatment
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* Device: Delefilcon A contact lenses with UV Absorber
* Device: Delefilcon A contact lenses


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must sign an Informed Consent document; Current wearers of commercial DT1 lenses (for at least 3 months), with a minimum wearing time of 5 days per week and 8 hours per day; Spherical contact lens correction within the range of -2.00 to -4.00 Diopter (D) in both eyes; Manifest astigmatism less than or equal to 0.75 D (at screening); Best-corrected visual acuity (BCVA) greater than or equal to 20/25 in each eye (as determined by manifest refraction at screening); 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 as determined by the Investigator; Use of systemic or ocular medications for which contact lens wear could be contraindicated, including topical ocular medications and lubrication drops that would require instillation during contact lens wear; History of herpetic keratitis; History of refractive surgery or irregular cornea; Pathologically dry eye that precludes contact lens wear; Concurrent participation (or within the previous 30 days) in a contact lens or lens care product clinical trial; 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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DT1 UV<br>Delefilcon A contact lenses with Ultraviolet (UV) Absorber worn bilaterally (in both eyes) for 9 hours | Device: Delefilcon A contact lenses with UV Absorber<br> <br> * Other names: DAILIES TOTAL1® UV (DT1 UV);|
| Active Comparator: DT1<br>Delefilcon A contact lenses worn bilaterally for 9 hours | Device: Delefilcon A contact lenses<br> <br> * Other names: DAILIES TOTAL1® (DT1);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence (Number) of Ocular Discomfort Device-related Adverse Events (AEs) | An AE was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. Reported in units of eyes. | Day 1 at Hour 9 ± 3 hours |