Clinical Comparison of DDT2 Contact Lens and a Daily Disposable Contact Lens

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

154 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-26

Study Completion Date

2019-06-28

Brief Summary

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The purpose of this study was to evaluate visual acuity at distance when wearing DDT2 contact lenses compared to Clariti contact lenses.

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Detailed Description

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Subjects were expected to attend 3 study visits and wear the DDT2 and Clariti study lenses in a crossover design for approximately 14 - 20 days (7 - 10 days for each product).

Conditions

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Refractive Error Myopia

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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DDT2, then Clariti

Verofilcon A contact lenses worn first, with somofilcon A contact lenses worn second, as randomized. Each product was worn bilaterally (in both eyes) for 8 -1/+2 days 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, then DDT2

Somofilcon A contact lenses worn first, with verofilcon A contact lenses worn second, as randomized. Each product was worn bilaterally (in both eyes) for 8 -1/+2 days 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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DDT2 clariti® 1 day Clariti

Eligibility Criteria

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Inclusion Criteria

* Able to understand and sign an Informed Consent Form that has been approved by an Institutional Review Board.
* Willing and able to attend all scheduled study visits as required per protocol.
* Current wearer of spherical soft contact lenses.