Daily Disposable Toric Comparative Trial in Europe

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Alcon Research ( CIBA VISION )

ClinicalTrials.gov Identifier:

NCT01070381

First received: February 16, 2010

Last updated: June 26, 2012

Last verified: January 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	February 16, 2010
Last Updated Date	June 26, 2012
Start Date ^ICMJE	January 2010
Primary Completion Date	March 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: February 25, 2011)	Overall Comfort [ Time Frame: 1 week of wear ] [ Designated as safety issue: No ] Overall Comfort, as interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of 1-week's wear time. Overall comfort is measured on a 10-point scale, with 1 being poor and 10 being excellent.
Original Primary Outcome Measures ^ICMJE (submitted: February 17, 2010)	lens fit [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Change History	Complete list of historical versions of study NCT01070381 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE (submitted: February 17, 2010)	visual acuity [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Daily Disposable Toric Comparative Trial in Europe
Official Title ^ICMJE	Not Provided
Brief Summary	The purpose of this study is to investigate the subjective and objective performance of two daily disposable lenses for wearers with astigmatism.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Myopia Astigmatism
Intervention ^ICMJE	Device: nelfilcon A contact lens Commercially marketed, toric, soft contact lens for daily disposable wear Device: ocufilcon D contact lens Commercially marketed, toric, soft contact lens for daily disposable wear
Study Arm (s)	nelfilcon A / ocufilcon D Nelfilcon A contact lenses worn first, with ocufilcon D contact lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each. Interventions: Device: nelfilcon A contact lens Device: ocufilcon D contact lens ocufilcon D / nelfilcon A Ocufilcon D contact lenses worn first, with nelfilcon A contact lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each. Interventions: Device: nelfilcon A contact lens Device: ocufilcon D contact lens
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
Enrollment ^ICMJE	220
Completion Date	March 2010
Primary Completion Date	March 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Current soft contact lens wearers able to be fit with soft toric lenses in the protocol-specified parameters. Achieve 0.5 or better distance visual acuity in each eye at time of dispense. Achieve acceptable or optimal fit in each eye at time of dispense. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Habitual daily disposable contact lens wearer. Sleeps in contact lenses overnight. Currently enrolled in an ophthalmic clinical trial. Other protocol-defined exclusion criteria may apply.
Gender	Both
Ages	Not Provided
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT01070381
Other Study ID Numbers ^ICMJE	P-346-C-008
Has Data Monitoring Committee	Not Provided
Responsible Party	Alcon Research ( CIBA VISION )
Study Sponsor ^ICMJE	CIBA VISION
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Alcon Research
Verification Date	January 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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