Product Performance of a Toric Contact Lens - Full Text View

Purpose

Product performance of a Bausch & Lomb Toric Contact Lens compared to Ciba Vision Focus Daily Toric Contact Lens

Condition	Intervention
Myopia Astigmatism	Device: Bausch & Lomb Toric Contact Lens Device: Ciba Vision Focus Dailies Toric Contact Lens

MedlinePlus related topics:

Eye Wear

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study

Official Title:	Product Performance of a Toric Contact Lens

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

Primary Outcome Measures:

Slit lamp findings [ Time Frame: at all visits ] [ Designated as safety issue: Yes ]
subject's symptoms and complaints [ Time Frame: at very visit ] [ Designated as safety issue: No ]
contact lens visual acuity [ Time Frame: at each visit ] [ Designated as safety issue: No ]

Enrollment:	220
Study Start Date:	April 2008
Study Completion Date:	June 2008
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Bausch & Lomb Toric Contact Lens	Device: Bausch & Lomb Toric Contact Lens daily wear contact lens
2: Active Comparator Ciba Vision Focus Dailies Toric Contact Lens	Device: Ciba Vision Focus Dailies Toric Contact Lens daily wear contact lens

Eligibility

Criteria

Inclusion Criteria:

subject is an adapted soft contact lens wearer with astigmatism of 0.50 D or greater
VA correctable to 0.3 logMar or better (driving vision)
Clear central cornea

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00658996

Locations


Malaysia
	Laser Focus Sdn Bhd, Vision Correction Centre
	Johor Bahru, Malaysia, 80400

Sponsors and Collaborators

Bausch & Lomb, Inc.

Investigators


Study Director:	Gerard Cairns, PhD, MCOptom.	Bausch & Lomb, Inc.

Principal Investigator:	Benny Chian, MCOptom, D.Opt	Laser Focus Sdn Bhd, Vision Correction Centre

More Information

Responsible Party:	Bausch & Lomb, Inc. ( Gerard Cairns, PhD, MCOptom. )
Study ID Numbers:	559
First Received:	April 12, 2008
Last Updated:	August 19, 2008
ClinicalTrials.gov Identifier:	NCT00658996
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Eye Diseases

Myopia

Refractive Errors

Astigmatism

ClinicalTrials.gov processed this record on October 17, 2008

Sponsored by:	Bausch & Lomb, Inc.
Information provided by:	Bausch & Lomb, Inc.
ClinicalTrials.gov Identifier:	NCT00658996