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.
Information provided by:
Vistakon Identifier:
First received: October 14, 2005
Last updated: January 30, 2009
Last verified: January 2009
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
Device: VISTAKON Contact Lens

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

Resource links provided by NLM:

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)

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided 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 processed this record on November 27, 2015