Clinical Evaluation of a Multifocal Contact Lens on Symptomatic Patients

This study has been completed.

Sponsor:

Collaborator:

Visioncare Research Ltd.

Information provided by:

Vistakon

ClinicalTrials.gov Identifier:

NCT01016652

First received: November 18, 2009

Last updated: January 21, 2010

Last verified: January 2010

History of Changes

Tracking Information
First Received Date ^ICMJE	November 18, 2009
Last Updated Date	January 21, 2010
Start Date ^ICMJE	October 2009
Primary Completion Date	January 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: November 18, 2009)	Subjective Vision [ Time Frame: After two weeks ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01016652 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: November 18, 2009)	Amplitude of Accommodation [ Time Frame: After two weeks ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Clinical Evaluation of a Multifocal Contact Lens on Symptomatic Patients
Official Title ^ICMJE	Not Provided
Brief Summary	The purpose of this study is to evaluate the effect of a multi-focal contact lens on symptomatic patients.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Condition ^ICMJE	Presbyopia
Intervention ^ICMJE	Device: Etafilcon A Multifocal Contact Lens Comparison of 2 soft contact lens designs. Device: Etafilcon A Contact Lens Comparison of 2 soft contact lens designs.
Study Arm (s)	Experimental: Etafilcon A Multifocal Intervention: Device: Etafilcon A Multifocal Contact Lens Active Comparator: Etafilicon A Intervention: Device: Etafilcon A 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	51
Completion Date	January 2010
Primary Completion Date	January 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: To have signed an informed consent form (documented by the investigator in the Case Report Form [CRF]). Be existing daily wear spherical single-vision soft CL wearers (no extended wear in the last 3 months, but silicone hydrogels in daily wear are allowed). Between 35 and 47 years of age (inclusive). Have a CL spherical distance requirement between -1.00D and -6.00D (-6.50D refractive) in both eyes. Refractive astigmatism of 0.75D or less in both eyes. Visual symptoms associated with near vision Be correctable to a visual acuity of 6/9 (20/30) or better in each eye. Have normal eyes with no evidence of abnormality or disease. For the purpose of this study a normal eye is defined as one having: No amblyopia. No evidence of lid abnormality or infection. No conjunctival abnormality or infection. No clinically significant slit lamp findings (i.e. stromal haze, staining, scarring, Vascularization, infiltrates or abnormal opacities). No other active ocular disease. Exclusion Criteria: Monovision user or multifocal CL wearer. Regular user of reading spectacles (i.e. daily usage). Requires concurrent ocular medication. Clinically significant (Grade 3 or 4) corneal stromal haze, corneal Vascularization, tarsal abnormalities, bulbar hyperemia, limbal hyperemia, or any other abnormality of the cornea that would contraindicate CL wear. Corneal staining Grade 3 in more than two regions. Has had any anterior ocular surgery. Has had any other ocular surgery or injury within 8 weeks immediately prior to enrollment for this study. Pre-existing ocular irritation that would preclude CL fitting. Keratoconus or other corneal irregularity.
Gender	Both
Ages	35 Years to 47 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01016652
Other Study ID Numbers ^ICMJE	CR-4558, VMFL-511
Has Data Monitoring Committee	No
Responsible Party	Tom Karkkainen, Johnson & Johnson Vision Care, Inc.
Study Sponsor ^ICMJE	Vistakon
Collaborators ^ICMJE	Visioncare Research Ltd.
Investigators ^ICMJE	Not Provided
Information Provided By	Vistakon
Verification Date	January 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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