Study Intended to Show That the VISTAKON Contact Lens is Safe and Effective for Use on an Extended-Wear Basis for up to 7 Days and 6 Nights at a Time.

This study has been completed.

First Received: October 14, 2005 Last Updated: January 30, 2009 History of Changes

Sponsored by:	Vistakon
Information provided by:	Vistakon
ClinicalTrials.gov Identifier:	NCT00241280

Purpose

Study in the US intended to show that the VISTAKON Contact Lens is safe and effective for use on an extended-wear basis for up to 7 days and 6 nights at a time

Condition	Intervention
Myopia	Device: VISTAKON Contact Lens

MedlinePlus related topics: Eye Wear

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Double-Blind, Active Control, Parallel Assignment

Further study details as provided by Vistakon:

Study Start Date:	September 2005
Study Completion Date:	October 2006
Primary Completion Date:	October 2006 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

At least 18 years of age
Minimum of 7 days of successful lens wear
Contact lens prescription requiring between -1.00 to -6.00 D spherical power
Less than 1.00 D of astigmatism in either eye

Exclusion Criteria:

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Study ID Numbers:	CR-1480
Study First Received:	October 14, 2005
Last Updated:	January 30, 2009
ClinicalTrials.gov Identifier:	NCT00241280 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Myopia

ClinicalTrials.gov processed this record on May 07, 2009