Comparative Performance of PureVision, Acuvue Oasys and O2Optix

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Bausch & Lomb Incorporated

ClinicalTrials.gov Identifier:

NCT00640341

First received: February 20, 2008

Last updated: December 7, 2011

Last verified: December 2011

History of Changes

Results First Received: February 3, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Single Blind (Subject); Primary Purpose: Supportive Care
Condition:	Myopia
Interventions:	Device: PureVision Contact Lens Device: Acuvue Oasys Contact Lens Device: O2Optix Contact lens

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
546 subjects (1092 eyes) were planned to be enrolled at 26 investigative sites in the US. First subject enrolled on 2/25/2008 and last subject seen was 4/28/2008.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
510 subjects (1020 eyes) were enrolled (all were dispensed). 477 subjects (954 eyes) completed the study. 10 subjects were ineligible at baseline and 23 were discontinued during the study.

Reporting Groups

	Description
PureVision	Redesigned PureVision Contact Lens. Lenses are to be worn on a daily wear basis.
Acuvue Oasys	Currently marketed Acuvue Oasys Contact Lens. Lenses are to be worn on a daily wear basis.
O2Optix	Currently marketed O2Optix Contact Lens. Lenses are to be worn on a daily wear basis.

Participant Flow: Overall Study

	PureVision	Acuvue Oasys	O2Optix
STARTED	170 ^[1]	170	170
Eligible Participants at Baseline	165	167	168
COMPLETED	149	165	163
NOT COMPLETED	21	5	7
Adverse Event	0	0	1
Positive Slit Lamp Findings	0	0	1
Study Related Symptoms/Complaints	2	1	2
Inability to Maintain Wearing Schedule	1	1	0
Failure to Follow Subject Instructions	1	0	0
Lost to Follow-up	2	0	0
Withdrawal by Subject	4	0	1
Unacceptable Lens Movement	1	0	0
Poor fit/Uncomfortable	4	0	0
Ineligable at Baseline	5	3	2
Adverse event and positive slit lamp	1	0	0

[1]	All Starting participants were dispensed lenses

Baseline Characteristics

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Reporting Groups

	Description
PureVision	Redesigned PureVision Contact Lens. Lenses are to be worn on a daily wear basis.
Acuvue Oasys	Currently marketed Acuvue Oasys Contact Lens. Lenses are to be worn on a daily wear basis.
O2Optix	Currently marketed O2Optix Contact Lens. Lenses are to be worn on a daily wear basis.
Total	Total of all reporting groups

Baseline Measures

	PureVision	Acuvue Oasys	O2Optix	Total
Number of Participants [units: participants]	165	167	168	500
Age, Customized [units: Participants]
Age 18 to 65 years	165	167	168	500
Gender [units: Participants]
Female	125	127	124	376
Male	40	40	44	124
Region of Enrollment [units: Participants]
United States	165	167	168	500

Outcome Measures

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1. Primary:

Any Slit Lamp Finding > Grade 2 [ Time Frame: Over all follow-up visits for the 1 month study period ]

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2. Primary:

Subjective Responses to Comfort-related Symptoms/Complaints [ Time Frame: Over all follow-up visits for 1 month study period ]

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3. Primary:

Uncorrected Distance High Contrast Visual Acuity [ Time Frame: Over all visits for the 1 month study period ]

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Serious Adverse Events

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Time Frame	1 month
Additional Description	No text entered.

Reporting Groups

	Description
PureVision	Redesigned PureVision Contact Lens. Lenses are to be worn on a daily wear basis.
Acuvue Oasys	Currently marketed Acuvue Oasys Contact Lens. Lenses are to be worn on a daily wear basis.
O2Optix	Currently marketed O2Optix Contact Lens. Lenses are to be worn on a daily wear basis.

Serious Adverse Events

	PureVision	Acuvue Oasys	O2Optix
Total, serious adverse events
# participants affected / at risk	0/340 (0.00%)	0/340 (0.00%)	0/340 (0.00%)

Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: The results of the study may be published or presented by the investigator(s) after the review by, and in consultation and agreement with the Sponsor, and such that confidential or proprietary information is not disclosed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Gerard Cairns
Organization: Bausch & Lomb Incorporated
phone: (585) 338-5170
e-mail: gerard.cairns@bausch.com

No publications provided

Responsible Party:	Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:	NCT00640341 History of Changes
Other Study ID Numbers:	552
Study First Received:	February 20, 2008
Results First Received:	February 3, 2011
Last Updated:	December 7, 2011
Health Authority:	United States: Institutional Review Board

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