Clinical Performance of a Silicone Hydrogel for Daily Disposable Wear

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-19

Study Completion Date

2017-05-15

Brief Summary

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The purpose of this study is to compare the visual acuity of an investigational silicone hydrogel to a commercially available silicone hydrogel in contact lens wearers.

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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

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Alcon Observer and Sponsor personnel were also masked.

Study Groups

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FID122819, then stenfilcon A

FID122819 contact lenses worn first, followed by stenfilcon A contact lenses, as randomized. Each product worn in both eyes in a daily disposable mode for at least 8 hours per day, 5 days per week, for 1 week

Group Type OTHER

FID122819 contact lenses

Intervention Type DEVICE

Investigational spherical silicone hydrogel contact lenses for daily disposable wear

Stenfilcon A contact lenses

Intervention Type DEVICE

Commercially available spherical silicone hydrogel contact lenses for daily disposable wear

Stenfilcon A, then FID122819

Stenfilcon A contact lenses worn first, followed by FID122819 contact lenses, as randomized. Each product worn in both eyes in a daily disposable mode for at least 8 hours per day, 5 days per week, for 1 week

Group Type OTHER

FID122819 contact lenses

Intervention Type DEVICE

Investigational spherical silicone hydrogel contact lenses for daily disposable wear

Stenfilcon A contact lenses

Intervention Type DEVICE

Commercially available spherical silicone hydrogel contact lenses for daily disposable wear

Interventions

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FID122819 contact lenses

Investigational spherical silicone hydrogel contact lenses for daily disposable wear

Intervention Type DEVICE

Stenfilcon A contact lenses

Commercially available spherical silicone hydrogel contact lenses for daily disposable wear

Intervention Type DEVICE

Other Intervention Names

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DDT2 Verofilcon A MyDay®

Eligibility Criteria

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Inclusion Criteria

* Able to understand and sign an IRB-approved Informed Consent Form;
* Successful wear of 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:
* Manifest cylinder of ≤ 0.75 diopter (D) in each eye;
* Best corrected visual acuity (BCVA) of 20/25 or better in each eye;

Exclusion Criteria

* Any anterior segment infection, inflammation, abnormality or disease (including systemic) that contraindicates contact lens wear, as determined by the Investigator;
* Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the Investigator;
* History of refractive surgery or plan to have refractive surgery during the study;
* Ocular or intraocular surgery within the previous 12 months or planned during the study;
* Current or history of pathologically dry eye in either eye that, in the opinion of the Investigator, would preclude contact lens wear;
* Any previous or current wear of MYDAY;
* Habitually wearing monovision or multifocal lenses during the last 3 months;
* Routinely sleeping in lenses for at least 1 night per week over the last 3 months prior to enrollment;
* Any use of topical ocular medications and artificial tear or rewetting drops that would require instillation during contact lens wear;

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No