Multi-Centre Clinical Evaluation Of Two Daily Disposable Contact Lenses

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Coopervision, Inc.

ClinicalTrials.gov Identifier:

NCT01707238

First received: September 21, 2012

Last updated: May 17, 2013

Last verified: May 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	September 21, 2012
Last Updated Date	May 17, 2013
Start Date ^ICMJE	October 2012
Primary Completion Date	January 2013 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: October 12, 2012)	Lens handling [ Time Frame: after 2 weeks of lens wear ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01707238 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Multi-Centre Clinical Evaluation Of Two Daily Disposable Contact Lenses
Official Title ^ICMJE	Not Provided
Brief Summary	The stenfilcon A daily disposable contact lens will provide non-inferior handling compared to etafilcon A daily disposable contact lens.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator)
Condition ^ICMJE	Myopia
Intervention ^ICMJE	Device: etafilcon A; stenfilcon A Device: stenfilcon A; etafilcon A
Study Arm (s)	Active Comparator: etafilcon A etafilcon A Interventions: Device: etafilcon A; stenfilcon A Device: stenfilcon A; etafilcon A Experimental: stenfilcon A stenfilcon A Interventions: Device: etafilcon A; stenfilcon A Device: stenfilcon A; etafilcon A
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	100
Completion Date	March 2013
Primary Completion Date	January 2013 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria:- Be between 16 and 45 years of age (inclusive) Adapted soft CL wearers (i.e. > 1 month) Spherical distance CL prescription between -1.00 and -6.00D (inclusive) Spectacle cylinder ≤0.75D in the least astigmatic eye, ≤1.00D in the other. Correctable to 6/9 (20/30) in both eyes Have the use of a mobile phone to send and receive text messages throughout the day for the duration of the study. Have read, understood and signed the informed consent Willing to comply with the wear schedule (at least 40 hours per week) 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 CL wear Systemic disease, which might interfere with CL wear Ocular disease, which might interfere with CL wear Strabismus, amblyopia Subjects who have undergone corneal refractive surgery and any anterior segment surgery Subjects with keratoconus or other severe corneal irregularity contraindicating lens wear Pregnant or lactating Use of systemic/topical medication contraindicating CL wear Use of gas permeable contact lenses within the last month Employees of the investigational site or immediate family members of Investigators Participation in any concurrent clinical trial or in the last 30 days
Gender	Both
Ages	16 Years to 45 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United Kingdom

Administrative Information
NCT Number ^ICMJE	NCT01707238
Other Study ID Numbers ^ICMJE	EX-MKTG-39
Has Data Monitoring Committee	Yes
Responsible Party	Coopervision, Inc.
Study Sponsor ^ICMJE	Coopervision, Inc.
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Coopervision, Inc.
Verification Date	May 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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