Clinical Comparison of DDT2 Contact Lens and a Daily Disposable Contact Lens - Study 1

Study Overview
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Brief Summary
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The purpose of this study was to evaluate visual acuity at distance when wearing DDT2 contact lenses compared to Acuvue Moist contact lenses.

Detailed Description
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Subjects were expected to attend 3 study visits and wear study lenses for approximately 14 - 20 days (7 - 10 days for each product).

Official Title
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Clinical Comparison of DDT2 Contact Lens and a Daily Disposable Contact Lens - Study 1

Conditions
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Refractive Error, Myopia

Intervention / Treatment
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* Device: Verofilcon A contact lenses
* Device: Etafilcon A contact lenses


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Able to understand and sign an Informed Consent Form that has been approved by an Institutional Review Board. Willing and able to attend all scheduled study visits as required per protocol. Current wearer of spherical soft contact lenses. Key Exclusion Criteria: Any ocular condition that contraindicates contact lens wear. Previous or current habitual wearer of ACUVUE® MOIST or DAILIES TOTAL1® contact lenses.

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: DDT2, then 1DAVM<br>Verofilcon A contact lenses worn first, with etafilcon A contact lenses worn second, as randomized. Each product was worn bilaterally (in both eyes) for 8 -1/+2 days in a daily disposable modality. | Device: Verofilcon A contact lenses<br>* Investigational daily disposable soft contact lenses<br>* Other names: DDT2;Device: Etafilcon A contact lenses<br>* Commercially available daily disposable soft contact lenses<br>* Other names: 1-DAY ACUVUE® MOIST;|
| Other: 1DAVM, then DDT2<br>Etafilcon A contact lenses worn first, with verofilcon A contact lenses worn second, as randomized. Each product was worn bilaterally (in both eyes) for 8 -1/+2 days in a daily disposable modality. | Device: Verofilcon A contact lenses<br>* Investigational daily disposable soft contact lenses<br>* Other names: DDT2;Device: Etafilcon A contact lenses<br>* Commercially available daily disposable soft contact lenses<br>* Other names: 1-DAY ACUVUE® MOIST;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Least Squares Mean Distance Visual Acuity With Study Lenses | Visual acuity was assessed and collected for each eye separately using logarithmic of the Minimum Angle of Resolution (logMAR) charts. A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity (normal visual acuity), with a negative value denoting better than 20/20 visual acuity. | Day 8, each product | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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VA, Visual acuity, Daily disposable contact lenses