Initial Performance of a Daily Disposable Contact Lens Featuring Molded Marks

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

87 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-14

Study Completion Date

2016-12-02

Brief Summary

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The purpose of this study is to evaluate the impact of back surface molded marks (MM) applied to delefilcon A contact lenses as measured by the incidence of ocular discomfort device-related adverse events with DAILIES TOTAL1® Multifocal contact lenses with molded marks (DT1 MF MM) and current DAILIES TOTAL1® Multifocal contact lenses (DT1 MF).

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Detailed Description

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Conditions

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Refractive Error

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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DT1 MF MM

Delefilcon A multifocal contact lenses with molded marks on back surface worn bilaterally (in both eyes) for 9 hours

Group Type EXPERIMENTAL

Delefilcon A Multifocal Contact Lenses with Molded Mark

Intervention Type DEVICE

DT1 MF

Delefilcon A multifocal contact lenses worn bilaterally for 9 hours

Group Type ACTIVE_COMPARATOR

Delefilcon A Multifocal Contact Lenses

Intervention Type DEVICE

Interventions

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Delefilcon A Multifocal Contact Lenses with Molded Mark

Intervention Type DEVICE

Delefilcon A Multifocal Contact Lenses

Intervention Type DEVICE

Other Intervention Names

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DAILIES TOTAL1® Multifocal (DT1 MF)

Eligibility Criteria

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Inclusion Criteria

* Must sign an Informed Consent document;
* Current wearer of commercial DAILIES TOTAL1® contact lenses;
* Have spectacles in current prescription available to be worn in conjunction with the investigational product;
* Manifest astigmatism less than or equal to 0.75 diopter (D) (at screening)
* Best corrected distance visual acuity (BCVA) greater than or equal to 20/25 in each eye;

Exclusion Criteria

* Eye injury in either eye within 12 weeks prior to study enrollment;
* Any anterior segment infection, inflammation, disease, or abnormality that contraindicates contact lens wear;
* Any use of systemic or ocular medications for which contact lens wear could be contraindicated;
* History of herpetic keratitis, refractive surgery or irregular cornea;
* A pathologically dry eye that precludes contact lens wear;
* Concurrent participation in a contact lens or contact lens care product clinical trial within the previous 30 days;
* Monocular (only 1 eye with functional vision);

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No