Retrospective Study of the Health Benefits of Ultra-Violet Filtering Contact Lenses

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Vistakon

ClinicalTrials.gov Identifier:

NCT01444053

First received: August 30, 2011

Last updated: May 7, 2012

Last verified: May 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	August 30, 2011
Last Updated Date	May 7, 2012
Start Date ^ICMJE	June 2011
Primary Completion Date	December 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: September 28, 2011)	Macular Pigment Ocular Density (MPOD) after 5 years of contact lens wear [ Time Frame: measured at a single visit ] [ Designated as safety issue: No ] The MPOD will be assessed at a single visit will be compared between wearers of contact lenses with UV protection and those wearers of lenses without UV protection, based on their 5 year wear history. Amplitude of Accommodation after 5 years of contact lens wear [ Time Frame: measured at a single visit ] [ Designated as safety issue: No ] Measured with autorefractor at a single visit and will be compared between wearers of contact lenses with UV protection and those wearers of lenses without UV protection, based on their 5 year wear history.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01444053 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	Retrospective Study of the Health Benefits of Ultra-Violet Filtering Contact Lenses
Official Title ^ICMJE	Not Provided
Brief Summary	The purpose of this study is to examine the long term effect of ultra-violet filtering contact lenses on macular pigment density (MPOD) and accommodative function.
Detailed Description	Not Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Case Control Time Perspective: Retrospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	Subject selection is based on a history of wearing one of two types of contact lenses for at least five years. Age-matching subjects into 4 age-brackets will be attempted with a target of five subjects in each age bracket among the two types of lenses.
Condition ^ICMJE	Refractive Errors
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	Wearers of contact lenses without UV Protection Subjects who have worn a soft contact lens without UV protection for the past five years or more. Wearers of contact lenses with UV Protection Subjects who have worn a soft contact lens with UV protection for the last 5 years or more.
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	41
Completion Date	December 2011
Primary Completion Date	December 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: The subject is an adapted soft contact lens wearer of at least 5 years duration of either an UV filtering contact lens or a non-UV filtering contact lens The subject must report wearing their contact lenses, on average, for a minimum of 5 days each week. The subject must have best corrected visual acuity of 6/7.5 or better in each eye. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol. The subject must read and sign the statement of informed consent The subject must be between 18 and 43 years of age Exclusion Criteria: On medication known to affect accommodation Active ocular surface pathology Had eye surgery Significant ocular tissue anomaly Any medical condition that may be prejudicial to the study Diabetes
Gender	Both
Ages	18 Years to 43 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	NCT01444053
Other Study ID Numbers ^ICMJE	CR-201010
Has Data Monitoring Committee	No
Responsible Party	Vistakon
Study Sponsor ^ICMJE	Vistakon
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Vistakon
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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