Prospective Study of an Investigational Daily Disposable Contact Lens

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Alcon Research ( CIBA VISION )

ClinicalTrials.gov Identifier:

NCT01295905

First received: February 11, 2011

Last updated: June 26, 2012

Last verified: May 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	February 11, 2011
Last Updated Date	June 26, 2012
Start Date ^ICMJE	January 2011
Primary Completion Date	May 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: May 18, 2012)	Corrected Distance Monocular Visual Measurement in Normal Illumination Reported as Visual Acuity [ Time Frame: 3 months of wear, lenses replaced daily ] [ Designated as safety issue: No ] Each eye tested individually while reading a chart distant to the participant in normal lighting. Visual acuity was measured using a Snellen chart, with 20/20 Snellen acuity considered normal distance-eyesight. Visual acuity is reported as the number of eyes achieving 20/20 Snellen acuity or better.
Original Primary Outcome Measures ^ICMJE (submitted: February 11, 2011)	Corrected distance monocular visual measurement in normal illumination reported as Visual Acuity [ Time Frame: 3 months of wear time ] [ Designated as safety issue: No ] Each eye tested individually while reading a chart distant to the participant in normal lighting. Visual acuity is measured using a Snellen chart. 20/20 Snellen acuity is considered normal distance-eyesight.
Change History	Complete list of historical versions of study NCT01295905 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: May 18, 2012)	Overall Vision [ Time Frame: 3 months of wear, lenses replaced daily ] [ Designated as safety issue: No ] As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 3 months of wear time. Overall vision was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent. Overall Comfort [ Time Frame: 3 months of wear, lenses replaced daily ] [ Designated as safety issue: No ] As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 3 months of wear time. Overall comfort was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent. Overall Handling [ Time Frame: 3 months of wear, lenses replaced daily ] [ Designated as safety issue: No ] As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 3 months of wear time. Overall handling was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent.
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	Prospective Study of an Investigational Daily Disposable Contact Lens
Official Title ^ICMJE	Not Provided
Brief Summary	The purpose of this study is to evaluate the performance of an investigational daily disposable contact lens.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Condition ^ICMJE	Myopia
Intervention ^ICMJE	Device: delefilcon A contact lens Investigational silicone hydrogel, single vision soft contact lens Device: narafilcon B contact lens Commercially marketed silicone hydrogel, single vision soft contact lens
Study Arm (s)	Experimental: delefilcon A Investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months. Intervention: Device: delefilcon A contact lens Active Comparator: narafilcon B Commercially marketed contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months. Intervention: Device: narafilcon B 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	90
Completion Date	May 2011
Primary Completion Date	May 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Subjects with normal eyes who are not using any ocular medications. Be of legal age of consent and sign Informed Consent document. If under legal age of consent, legally authorized representative must sign Informed Consent document and subject must sign Assent document. Willing and able to wear spherical contact lenses for at least 5 days per week. Willing and able to wear spherical contact lenses within the available range of powers of -1.00 diopter(D) to -6.00D in 0.25D steps. Best spectacle-corrected visual acuity greater than or equal to 20/25. Manifest cylinder less than or equal to 0.75D. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Any active anterior segment ocular disease that would contraindicate contact lens wear. Any use of systemic medications for which contact lens wear could be contraindicated as determined by the investigator. History of refractive surgery or irregular cornea. History of pathologically dry eye. Eye injury within twelve weeks immediately prior to enrollment for this trial. Currently enrolled in any clinical trial. Participation in a contact lens or contact lens care product clinical trial within the previous 30 days. 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	NCT01295905
Other Study ID Numbers ^ICMJE	P-347-C-004
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	May 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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