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.

Sponsor:

Information provided by:

Vistakon

ClinicalTrials.gov Identifier:

NCT00241280

First received: October 14, 2005

Last updated: January 30, 2009

Last verified: January 2009

History of Changes

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double-Blind

Resource links provided by NLM:

MedlinePlus related topics: Eye Wear

U.S. FDA Resources

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

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

Additional relevant MeSH terms:

Myopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on June 17, 2013

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