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Multi-Center Clinical Evaluation of Two Daily Disposable Contact Lenses (Study 2)

NCT ID: NCT01917162

Last Updated: 2013-11-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2013-11-30

Brief Summary

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The purpose of this study is to compare the subjective performance of two daily disposable contact lenses with respect to comfort and handling.

Detailed Description

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Conditions

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Refractive Error

Keywords

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contact lenses daily disposable contact lenses silicone hydrogel contact lens comfort near-sighted

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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Nelfilcon A/UltraFilcon B

Nelfilcon A contact lenses, followed by UltraFilcon B contact lenses. Each product worn bilaterally for one week in a daily wear, daily disposable modality.

Group Type OTHER

Nelfilcon A contact lens

Intervention Type DEVICE

Soft contact lens CE-marked for daily disposable wear.

UltraFilcon B contact lens

Intervention Type DEVICE

Silicone hydrogel soft contact lens CE-marked for daily disposable wear. Private-label versions may be used.

UltraFilcon B/Nelfilcon A

UltraFilcon B contact lenses, followed by Nelfilcon A contact lenses. Each product worn bilaterally for one week in a daily wear, daily disposable modality.

Group Type OTHER

Nelfilcon A contact lens

Intervention Type DEVICE

Soft contact lens CE-marked for daily disposable wear.

UltraFilcon B contact lens

Intervention Type DEVICE

Silicone hydrogel soft contact lens CE-marked for daily disposable wear. Private-label versions may be used.

Interventions

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Nelfilcon A contact lens

Soft contact lens CE-marked for daily disposable wear.

Intervention Type DEVICE

UltraFilcon B contact lens

Silicone hydrogel soft contact lens CE-marked for daily disposable wear. Private-label versions may be used.

Intervention Type DEVICE

Other Intervention Names

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DAILIES® AquaComfort Plus® Procornea BYO Air Daily

Eligibility Criteria

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Inclusion Criteria

* Adapted soft contact lens wearer;
* Spherical distance contact lens prescription between -1.00 and -6.00 diopter (inclusive);
* Spectacle cylinder ≤0.75 diopter in the least astigmatic eye, ≤1.00 diopter in the other;
* Correctable to 6/9 (20/30) in both eyes;
* Read, understand, and sign the informed consent;
* Willing to comply with the wear schedule;
* Willing to comply with the study visit schedule;

Exclusion Criteria

* Any active corneal infection, injury or inflammation;
* Systemic or ocular allergies which might interfere with contact lens wear;
* Systemic or ocular disease which might interfere with contact lens wear;
* Strabismus or amblyopia;
* Corneal refractive surgery and any anterior segment surgery;
* Use of systemic/topical medication contraindicating contact lens wear;
* Use of gas permeable contact lenses within 1 month preceding the study;
* Participation in any concurrent clinical trial or in the last 30 days;
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 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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Joachim Nick, Dipl. Ing.

Role: STUDY_DIRECTOR

Alcon Research

Locations

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Visioncare Research Ltd

Farnham, Surrey, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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C-13-033

Identifier Type: -

Identifier Source: org_study_id