Clinical Performance of Atypical Contact Lens Powers on Subjects With Astigmatism - Full Text View

Sponsored by:	Vistakon
Information provided by:	Vistakon
ClinicalTrials.gov Identifier:	NCT00697190

Purpose

This study will evaluate the fitting characteristics and physiological response of two toric lenses manufactured by Vistakon.

Condition	Intervention
Astigmatism	Device: Acuvue Oasys for Astigmatism Device: Acuvue Advance for Astigmatism

MedlinePlus related topics: Eye Wear

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Active Control, Crossover Assignment, Safety/Efficacy Study

Further study details as provided by Vistakon:

Primary Outcome Measures:

Physical fit [ Time Frame: after 6 hours of wear ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Physiology. [ Time Frame: after 6 hours of wear ] [ Designated as safety issue: Yes ]

Enrollment:	39
Study Start Date:	May 2008
Study Completion Date:	September 2008
Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Acuvue Oasys for Astigmatism	Device: Acuvue Oasys for Astigmatism Contact lens
2: Active Comparator Acuvue Advance for Astigmatism	Device: Acuvue Advance for Astigmatism Contact lens

Eligibility

Criteria

Inclusion Criteria:

Able to wear study lenses in parameters available.
At least 18
understand and sign informed consent
willing to follow the protocol
achieve at least 6/9 VA OU with study lenses
hyperopes: +2.00 to +4.00 with -0.75 D cyl around 180, high myopes: -6.00 to -8.00 with -1.25 D cyl around 180
oblique axis: -2.00 to -4.00 with -0.75 D cyl around 45 or 135, have worn SCL's within last 6 months

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00697190

Locations

Sponsors and Collaborators

Vistakon

More Information

Responsible Party:	Vistakon ( John Buch/Principal Research Optometrist )
Study ID Numbers:	CR-4523
Study First Received:	June 10, 2008
Last Updated:	January 8, 2009
ClinicalTrials.gov Identifier:	NCT00697190
Health Authority:	United Kingdom: Research Ethics Committee

Study placed in the following topic categories:

Eye Diseases
Refractive Errors
Astigmatism

ClinicalTrials.gov processed this record on January 15, 2009