Clinical Comparison of 4 Daily Disposable Soft Contact Lenses

Study Overview
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Brief Summary
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The purpose of this study is to obtain on-eye performance data to inform contact lens product development and to further evaluate product performance in the intended population.

Detailed Description
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The expected duration of subject participation in the study is approximately 20 days with 3 scheduled visits. Each subject will evaluate the test contact lenses compared to 1 of 3 commercially available contact lenses.

Official Title
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Clinical Comparison of 4 Daily Disposable Soft Contact Lenses

Conditions
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Refractive Error

Intervention / Treatment
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* Device: verofilcon A contact lenses
* Device: senofilcon A contact lenses
* Device: stenfilcon A contact lenses
* Device: etafilcon A contact lenses


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Able to understand and must sign an approved Informed Consent Form Successfully wears daily disposable spherical soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months Best Corrected Visual Acuity of 20/25 Snellen or better in each eye Willing to stop wearing habitual contact lenses for the duration of study participation Other protocol-defined inclusion criteria may apply Exclusion Criteria: Any eye condition, surgery, disease, or use of medication that contraindicates contact lens wear, as determined by the Investigator. Routinely sleeps in habitual contact lenses Currently wears Oasys 1-Day, MyDay, or Moist contact lenses Other protocol-defined 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: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: DD T2/Oasys 1-Day<br>Verofilcon A contact lenses and senofilcon A contact lenses worn in both eyes, each product, for 1 week on a daily wear basis, as randomized | Device: verofilcon A contact lenses<br>* Investigational spherical silicone hydrogel contact lenses for daily disposable wear<br>* Other names: DDT2;Device: senofilcon A contact lenses<br>* Commercially available spherical silicone hydrogel contact lenses for daily disposable wear<br>* Other names: Oasys 1-Day;|
| Other: DD T2/MyDay<br>Verofilcon A contact lenses and stenfilcon A contact lenses worn in both eyes, each product, for 1 week on a daily disposable basis, as randomized | Device: verofilcon A contact lenses<br>* Investigational spherical silicone hydrogel contact lenses for daily disposable wear<br>* Other names: DDT2;Device: stenfilcon A contact lenses<br>* Commercially available spherical silicone hydrogel contact lenses for daily disposable wear<br>* Other names: MyDay;|
| Other: DD T2/Moist<br>Verofilcon A contact lenses and etafilcon A contact lenses worn in both eyes, each product, for 1 week on a daily disposable basis, as randomized | Device: verofilcon A contact lenses<br>* Investigational spherical silicone hydrogel contact lenses for daily disposable wear<br>* Other names: DDT2;Device: etafilcon A contact lenses<br>* Commercially available spherical silicone hydrogel contact lenses for daily disposable wear<br>* Other names: Moist;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Quality of Vision | Overall quality of vision was collected binocularly and rated on a 10-point scale with 1 = poor to 10 = excellent. Subjects were asked Thinking back over the last week, please rate our study lenses. Rate eyes together. No formal hypotheses was conducted; hence no inferential testing was performed. | Day 8, each product | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Contact lenses, Myopia, Near-sighted, Daily disposable