Clinical Comparison of Two Daily Disposable Soft Contact Lenses

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-23

Study Completion Date

2018-06-11

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.

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Detailed Description

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Conditions

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Myopia Refractive Errors

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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DD T2, then Clariti 1 Day

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.

Group Type OTHER

verofilcon A contact lenses

Intervention Type DEVICE

Investigational daily disposable soft contact lenses

somofilcon A contact lenses

Intervention Type DEVICE

Commercially available daily disposable soft contact lenses

Clariti 1 Day, then DD T2

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.

Group Type OTHER

verofilcon A contact lenses

Intervention Type DEVICE

Investigational daily disposable soft contact lenses

somofilcon A contact lenses

Intervention Type DEVICE

Commercially available daily disposable soft contact lenses

Interventions

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verofilcon A contact lenses

Investigational daily disposable soft contact lenses

Intervention Type DEVICE

somofilcon A contact lenses

Commercially available daily disposable soft contact lenses

Intervention Type DEVICE

Other Intervention Names

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DD T2 clariti® 1 day Clariti 1 Day

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;

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;

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No