Clinical Comparison of Two Daily Disposable Soft Contact Lenses

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the overall performance of investigational contact lenses (DD T2) when compared to clariti® 1 day contact lenses.

Official Title
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Clinical Comparison of Two Daily Disposable Soft Contact Lenses

Conditions
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Myopia, Refractive Errors

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Understand and sign an Informed Consent Form; Successful wear of 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 (BCVA) 20/25 or better in each eye; Willing to stop wearing habitual contact lenses for the duration of study participation; Other protocol-specified inclusion criteria may apply. Exclusion Criteria: Anterior segment infection, inflammation, or abnormality or disease that contraindicates contact lens wear, as determined by the Investigator; Use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the Investigator; Refractive, ocular, or intraocular surgery, as specified in the protocol; Eye condition or injury, as specified in the protocol; Current or history of intolerance, hypersensitivity, or allergy to any component of the study products; 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; Use of topical ocular medications and artificial tear or rewetting drops requiring instillation during contact lens wear; Currently wearing clariti® 1 day contact lenses; Habitually wearing monovision or multifocal lenses during the last 3 months; 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: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: DD T2, then Clariti 1 Day<br>Verofilcon A contact lenses worn first, with somofilcon A contact lenses worn second. Each product worn bilaterally (in both eyes) for 1 week in a daily disposable modality. | Device: verofilcon A contact lenses<br>* Investigational daily disposable soft contact lenses<br>* Other names: DD T2;Device: somofilcon A contact lenses<br>* Commercially available daily disposable soft contact lenses<br>* Other names: Clariti 1 Day;|
| Other: Clariti 1 Day, then DD T2<br>Somofilcon A contact lenses worn first, with verofilcon A contact lenses worn second. Each product worn bilaterally for 1 week in a daily disposable modality. | Device: verofilcon A contact lenses<br>* Investigational daily disposable soft contact lenses<br>* Other names: DD T2;Device: somofilcon A contact lenses<br>* Commercially available daily disposable soft contact lenses<br>* Other names: Clariti 1 Day;|

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 measured as a subjective rating, collected binocularly on a scale of 1 (Poor) to 10 (Excellent). No inferences were made; therefore, no hypotheses were formulated. | Day 8, each product | 

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