Clinical Validation of DACP Digital Design

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

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-25

Study Completion Date

2018-08-26

Brief Summary

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The purpose of this study is to evaluate the visual performance of DAILIES® AquaComfort Plus® (DACP) Digital lenses by assessing distance visual acuity (VA) as compared to DACP sphere contact lenses after one week of wear.

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Detailed Description

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Conditions

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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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DACP Digital then DACP

Nelfilcon A digital contact lenses worn first, followed by nelfilcon A contact lenses. Each product worn bilaterally (in both eyes) for 7 days in a daily disposable modality.

Group Type OTHER

Nelfilcon A digital contact lenses

Intervention Type DEVICE

Silicone hydrogel digital contact lenses

Nelfilcon A contact lenses

Intervention Type DEVICE

Silicone hydrogel spherical contact lenses

DACP then DACP Digital

Nelfilcon A contact lenses worn first, followed by nelfilcon A digital contact lenses. Each product worn bilaterally for 7 days in a daily disposable modality.

Group Type OTHER

Nelfilcon A digital contact lenses

Intervention Type DEVICE

Silicone hydrogel digital contact lenses

Nelfilcon A contact lenses

Intervention Type DEVICE

Silicone hydrogel spherical contact lenses

Interventions

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Nelfilcon A digital contact lenses

Silicone hydrogel digital contact lenses

Intervention Type DEVICE

Nelfilcon A contact lenses

Silicone hydrogel spherical contact lenses

Intervention Type DEVICE

Other Intervention Names

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DAILIES® AquaComfort Plus® Digital DACP Digital DAILIES® AquaComfort Plus® DACP

Eligibility Criteria

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Inclusion Criteria

* Willing and able to sign an IRB/IEC approved Informed Consent form;
* Current wearer of DACP spherical contact lenses (at least 2 months in current correction), with a minimum wearing time of 5 days per week and 8 hours per day;
* Experiencing symptoms of eye strain from using technology;
* Willing to wear study lenses each day;
* Possess spectacles that provide a corrected visual acuity of 20/40 or better in both eyes (OU) and be willing to wear them (as needed);
* Willing to NOT use rewetting/lubricating drops at any time during the study;
* Currently using digital devices (computer, tablet, and/or smart phone) for a minimum of 5 days per week and 4 hours per day;
* Willing to NOT use any near aid (e.g. reading glasses) at any time during the study.

Exclusion Criteria

* Conditions, use of medications, injury, or surgery, as specified in the protocol;
* 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;
* Monocular (only one eye with functional vision);
* Pregnant.

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No