Clinical Comparison of Two Daily Disposable Lenses Among Daily Disposable Lens Wearers

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Alcon Research ( CIBA VISION )

ClinicalTrials.gov Identifier:

NCT01134211

First received: May 27, 2010

Last updated: June 26, 2012

Last verified: October 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	May 27, 2010
Last Updated Date	June 26, 2012
Start Date ^ICMJE	May 2010
Primary Completion Date	July 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: May 27, 2010)	subjective ratings and preferences [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01134211 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE (submitted: May 27, 2010)	lens fit [ Time Frame: 2 weeks ] [ Designated as safety issue: No ] surface characteristics [ 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	Clinical Comparison of Two Daily Disposable Lenses Among Daily Disposable Lens Wearers
Official Title ^ICMJE	Not Provided
Brief Summary	The primary objective of this trial is to evaluate the subjective performance of two different daily disposable contact lenses in a population of daily disposable lens wearers.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Crossover Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Condition ^ICMJE	Myopia
Intervention ^ICMJE	Device: nelfilcon A Commercially marketed, single-vision, soft contact lens for daily disposable wear Device: filcon II 3 Commercially marketed, single-vision, soft contact lens for daily disposable wear
Study Arm (s)	nelfilcon A / filcon II 3 Nelfilcon A contact lenses worn first, with filcon II 3 contact lenses worn second. Both products worn in both eyes on a daily wear, daily disposable basis for one week each. Interventions: Device: nelfilcon A Device: filcon II 3 filcon II 3 / nelfilcon A Filcon II 3 contact lenses worn first, with nelfilcon A contact lenses worn second. Both products worn in both eyes on a daily wear, daily disposable basis for one week each. Interventions: Device: nelfilcon A Device: filcon II 3
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	316
Completion Date	July 2010
Primary Completion Date	July 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Currently wearing any spherical daily disposable lens in daily wear, daily disposable modality for at least 3 months prior to enrollment with the exception of the 2 study products Currently Wearing lenses at least 8 hrs/day and 5 days/week. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Eye injury or surgery within twelve weeks immediately prior to enrollment for this trial. Pre-existing ocular irritation that would preclude contact lens fitting. Currently enrolled in any clinical trial. Evidence of systemic or ocular abnormality, infection, or disease which is likely to affect successful wear of contact lenses or use of their accessory solutions as determined by the investigator. Any use of medications for which contact lens wear could be contraindicated as determined by the investigator. Prior history of corneal or refractive surgery. Requires monovision correction. 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	Germany

Administrative Information
NCT Number ^ICMJE	NCT01134211
Other Study ID Numbers ^ICMJE	P-337-C-033
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	October 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top