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

Clinical Performance of Atypical Contact Lens Powers on Subjects With Astigmatism

This study is currently recruiting participants.
Verified by Vistakon, June 2008

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

U.S. FDA Resources

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 ]

Estimated Enrollment:	60
Study Start Date:	May 2008
Estimated Study Completion Date:	July 2008
Estimated Primary Completion Date:	July 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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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:

Any ocular or systemic disorder which may contraindicate CL wear
any topical ocular medication
aphakic
corneal refractive surgery,
corneal distortion from hard CL wear or keratoconus
pregnant or lactating
grade 2 or worse slit lamp signs
infectious disease
previous clinical study within 2 weeks
don't agree to participate

Contacts and Locations

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

Contacts


Contact: Phil Morgan, PhD MCOptom	44-016-1306-4441

Locations


United Kingdom
	Eurolens Research	Recruiting
	Manchester, United Kingdom
	Contact: Philip Morgan, PhD MCOptom
	Principal Investigator: Phil Morgan, PhD MCOptom

Sponsors and Collaborators

Vistakon

More Information

Responsible Party:	Vistakon ( John Buch/Principal Research Optometrist )
Study ID Numbers:	CR-4523
First Received:	June 10, 2008
Last Updated:	June 12, 2008
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 October 28, 2008