Comparative Performance of PureVision Lens Designs - Full Text View

Sponsored by:	Bausch & Lomb, Inc.
Information provided by:	Bausch & Lomb, Inc.
ClinicalTrials.gov Identifier:	NCT00661687

Purpose

The objective of this study is to evaluate the performance of the PureVision Lens designs when worn on a 30-day continuous wear basis

Condition	Intervention
Myopia	Device: Currently Marketed Bausch & Lomb PureVision Soft Contact Lens. Device: Alternate Design of the Bausch & Lomb PureVision Soft Contact Lens.

MedlinePlus related topics: Eye Wear

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

Further study details as provided by Bausch & Lomb, Inc.:

Primary Outcome Measures:

Subjective responses to symptoms/complaints [ Time Frame: at any visit ] [ Designated as safety issue: No ]
Slit lamp findings and adverse events [ Time Frame: at any visit ] [ Designated as safety issue: No ]

Enrollment:	206
Study Start Date:	December 2007
Study Completion Date:	June 2008
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator PureVision Contact Lens Design #1.	Device: Currently Marketed Bausch & Lomb PureVision Soft Contact Lens. contact lens for continuous wear
2: Experimental PureVision Contact Lens Design #2.	Device: Alternate Design of the Bausch & Lomb PureVision Soft Contact Lens. contact lens for continuous wear

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00661687

Locations

Malaysia
Laser Focus Sdn Bhd, Vision Correction Centre
Johor Bahru, Malaysia, 80400
Philippines
Asian Eye Institute
Makati City, Philippines, 1200

Sponsors and Collaborators

Bausch & Lomb, Inc.

Investigators

Study Director:	Gerard Cairns, MCOptom, PhD	Bausch & Lomb, Inc.
Principal Investigator:	Benny Chian, MCOptom	Laser Focus Sdn Bhd, Vision Correction Centre
Principal Investigator:	Harvey Siy Uy, MD	Asian Eye Institute

More Information

Responsible Party:	Bausch & Lomb, Inc. ( Gerard Cairns, MCOptom, Ph.D. )
Study ID Numbers:	544
Study First Received:	April 16, 2008
Last Updated:	August 20, 2008
ClinicalTrials.gov Identifier:	NCT00661687
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Myopia

ClinicalTrials.gov processed this record on January 15, 2009