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Comparison of Two Daily Disposable Lenses

NCT ID: NCT04013789

Last Updated: 2020-11-24

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

79 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-27

Study Completion Date

2019-11-22

Brief Summary

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The purpose of this study was to compare the clinical performance of the new DAILIES® AquaComfort PLUS® FreshTech (DACP FreshTech) contact lenses to an already marketed daily disposable contact lens, DAILIES® AquaComfort PLUS® (DACP).

Detailed Description

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Subjects attended 4 scheduled visits for an expected duration of participation of 3 weeks.

Conditions

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Refractive Ametropia Myopia

Keywords

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eye strain eye fatigue

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 FreshTech, then DACP

DACP FreshTech contact lenses worn first, followed by DACP contact lenses, as randomized. Each product was worn in both eyes for approximately 8 hours per day for 1 week with a new pair of lenses worn each day.

Group Type OTHER

DACP FreshTech contact lenses

Intervention Type DEVICE

Nelfilcon A soft contact lenses with a modified lens design

DACP contact lenses

Intervention Type DEVICE

Nelfilcon A soft contact lenses

DACP, then DACP FreshTech

DACP contact lenses worn first, followed by DACP FreshTech contact lenses, as randomized.. Each product was worn in both eyes for approximately 8 hours per day, for 1 week with a new pair of lenses worn each day.

Group Type OTHER

DACP FreshTech contact lenses

Intervention Type DEVICE

Nelfilcon A soft contact lenses with a modified lens design

DACP contact lenses

Intervention Type DEVICE

Nelfilcon A soft contact lenses

Interventions

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DACP FreshTech contact lenses

Nelfilcon A soft contact lenses with a modified lens design

Intervention Type DEVICE

DACP contact lenses

Nelfilcon A soft contact lenses

Intervention Type DEVICE

Other Intervention Names

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DAILIES® AquaComfort PLUS® FreshTech DAILIES® AquaComfort PLUS®

Eligibility Criteria

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Inclusion Criteria

* At least 3 months of soft contact lens wearing experience;
* Wears habitual lenses at least 5 days per week and at least 8 hours per day;
* Uses digital devices (computer, tablet, and/or smart phone) for an average of 4 hours per day;
* Experiences eye fatigue at least once per week attributable to digital device use with habitual lenses;
* Is willing to NOT use rewetting/lubricating drops during the period of study product exposure;

Exclusion Criteria

* Routinely sleeps in contact lenses;
* Known pregnancy at time of enrollment;
* Binocular vision issues or issues of eye alignment;
* Any eye infection, inflammation, disease or abnormality that contraindicates contact lens wear;
* Use of medications as specified in the protocol;
* Ocular surgery within the past 12 months;
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alcon Research

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sr. Clinical Project Lead

Role: STUDY_DIRECTOR

Alcon Research

Locations

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Alcon Investigative Site

Bloomington, Indiana, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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CLD523-P001

Identifier Type: -

Identifier Source: org_study_id