DD T2 Daily Disposable Registration Trial

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the performance of the investigational verofilcon A contact lens compared to the commercially available delefilcon A contact lens, by assessing visual acuity as the primary variable.

Detailed Description
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Enrolled participants will be randomized (2:1) to receive either verofilcon A (test) contact lenses or delefilcon A (control) contact lenses for wear in both eyes and attend 7 office visits: Baseline, Dispense, 1-week follow-up, 2-week follow-up, 1-month follow-up, 2-month follow-up and 3-month follow-up/Exit.

Official Title
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DD T2 Daily Disposable Registration Trial

Conditions
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Myopia, Refractive Errors

Intervention / Treatment
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* Device: verofilcon A contact lenses
* Device: delefilcon A contact lenses


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Successful wear of spherical soft contact lenses for distance correction in both eyes during the past 3 months for a minimum of 5 days per week and 8 hours per day. Best corrected VA 20/25 or better in each eye. Other protocol-specified inclusion criteria may apply. Exclusion Criteria Any current or prior wear experience with DT1 lenses. Wearing habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment. 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DD T2<br>Verofilcon A contact lenses worn in both eyes for 3 months in a daily wear, daily disposable modality. A new pair of study lenses will be inserted each day and discarded at the end of the day. | Device: verofilcon A contact lenses<br>* Daily disposable soft contact lenses<br>* Other names: DD T2;|
| Active Comparator: DT 1<br>Delefilcon A contact lenses worn in both eyes for 3 months in a daily wear, daily disposable modality. A new pair of study lenses will be inserted each day and discarded at the end of the day. | Device: delefilcon A contact lenses<br>* Daily disposable soft contact lenses<br>* Other names: DT1;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Monocular Visual Acuity (VA) With Contact Lenses at Each Visit (Snellen) | VA was assessed for each eye individually using a Snellen chart at a distance of 4 meters. A 20/20 Snellen acuity is considered normal distance eyesight. No formal hypotheses were formulated; hence no inferential testing was performed. | Dispense, Week 1, Week 2, Month 1, Month 2, Month 3 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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soft contact lenses, vision, eyesight