DD T2 Daily Disposable Registration Trial

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

107 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-12

Study Completion Date

2018-02-21

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.

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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.

Conditions

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Myopia Refractive Errors

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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DD T2

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.

Group Type EXPERIMENTAL

verofilcon A contact lenses

Intervention Type DEVICE

Daily disposable soft contact lenses

DT 1

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.

Group Type ACTIVE_COMPARATOR

delefilcon A contact lenses

Intervention Type DEVICE

Daily disposable soft contact lenses

Interventions

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verofilcon A contact lenses

Daily disposable soft contact lenses

Intervention Type DEVICE

delefilcon A contact lenses

Daily disposable soft contact lenses

Intervention Type DEVICE

Other Intervention Names

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DD T2 DAILIES TOTAL1® DT1

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.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No