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A Lifestyle Investigation With Spectacles and Daily Disposable Contact Lenses in Young Patients

NCT ID: NCT01445652

Last Updated: 2013-09-19

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

113 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2012-06-30

Brief Summary

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The purpose of this study was to evaluate the relative benefits of daily disposable contact lenses versus spectacles in young adults.

Detailed Description

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Conditions

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Myopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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nelfilcon A

Nelfilcon A contact lenses worn in both eyes on a daily disposable basis a minimum of five days per week, eight hours per day, for six months

Group Type EXPERIMENTAL

nelfilcon A contact lens

Intervention Type DEVICE

Commercially marketed, single vision, soft contact lens for daily disposable wear

Spectacles

Spectacles per current prescription worn a minimum of five days per week, eight hours per day, for six months

Group Type ACTIVE_COMPARATOR

Spectacles

Intervention Type OTHER

Spectacles per current prescription

Interventions

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nelfilcon A contact lens

Commercially marketed, single vision, soft contact lens for daily disposable wear

Intervention Type DEVICE

Spectacles

Spectacles per current prescription

Intervention Type OTHER

Other Intervention Names

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DAILIES AQUACOMFORT PLUS

Eligibility Criteria

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Inclusion Criteria

* Understands rights as a research subject and willing and able to sign a Statement of Informed Consent, or if under 18, parent or guardian understands rights and is willing and able to sign a Statement of Informed Consent.
* Willing and able to follow the protocol.
* Currently wearing spectacles full-time (at least five days per week, eight hours per day).
* Has never worn contact lenses (more than one day) before.
* Agrees to not participate in other clinical research for the duration of this study.
* Can attain at least 6/9 in each eye with the study optical correction.
* Can be fitted with study lenses in the available power range (contact lens group) or can select a satisfactory spectacle lens frame and lenses (spectacle group).
* Willing and able to wear the study lenses or spectacles for a minimum of five days per week, eight hours per day.
* Owns or has regular access to a mobile phone and is familiar with SMS text messaging.
* Has an up-to-date and functional pair of spectacles at time of enrollment.

Exclusion Criteria

* Has an ocular or systemic disorder that would normally contraindicate contact lens wear.
* Is using any topical medication such as eye drops or ointment.
* Has had corneal refractive surgery.
* Has had cataract surgery.
* Has diabetes.
* Has taken part in other clinical research within two weeks of starting the study.
Minimum Eligible Age

13 Years

Maximum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Manchester

OTHER

Sponsor Role collaborator

CIBA VISION

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Philip Morgan, PhD MCOptom FAAO FBCLA

Role: PRINCIPAL_INVESTIGATOR

University of Manchester

Locations

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Eurolens Research

Manchester, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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P-370-C-091 / CB11-500

Identifier Type: -

Identifier Source: org_study_id