Safety and Efficacy of a Bausch & Lomb Multipurpose Solution When Compared to Ciba Vision Aquify Multipurpose Solution

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Bausch & Lomb Incorporated

ClinicalTrials.gov Identifier:

NCT00636363

First received: March 7, 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: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Supportive Care
Condition:	Contact Lens Solutions
Interventions:	Device: Bausch & Lomb Multipurpose Solution - Rub Care Device: Bausch & Lomb Multipurpose Solution - No Rub Care Device: Ciba Vision Aquify Multipurpose Solution

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
541 participants were enrolled in this 3 month study (1152 eyes). First participant was enrolled Mar 7, 2008 and last participant exited Aug 1, 2008. Participant were enrolled from 24 investigative sites in the US.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of the 541 participants enrolled 6 were ineligible at baseline. These subjects met the exclusion criteria. 535 participants participated in the study.

Reporting Groups

	Description
Multipurpose Solution - Rub Care	Bausch & Lomb Multipurpose Solution for use with contact lens care
Multipurpose Solution - No Rub Care	Bausch & Lomb Multipurpose Solution for use with contact lens care
Ciba Vision Aquify Multipurpose Solution	Ciba Vision Aquify Multipurpose Solution for use with contact lens care

Participant Flow: Overall Study

	Multipurpose Solution - Rub Care	Multipurpose Solution - No Rub Care	Ciba Vision Aquify Multipurpose Solution
STARTED	178	176	181
COMPLETED	165	156	163
NOT COMPLETED	13	20	18
Conjunctivitis	0	0	1
Adverse Event	0	0	1
Positive slit lamp finding	0	2	1
Study related symptoms/complaints	8	7	4
Met ineligibility criteria	0	0	3
Missed > 1 visit	0	1	3
Lack of motivation	1	0	1
Protocol Violation	0	3	0
Lost to Follow-up	3	4	2
Withdrawal by Subject	1	3	2

Baseline Characteristics

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Reporting Groups

	Description
Multipurpose Solution - Rub Care	Bausch & Lomb Multipurpose Solution for use with contact lens care
Multipurpose Solution - No Rub Care	Bausch & Lomb Multipurpose Solution for use with contact lens care
Ciba Vision Aquify Multipurpose Solution	Ciba Vision Aquify Multipurpose Solution for use with contact lens care
Total	Total of all reporting groups

Baseline Measures

	Multipurpose Solution - Rub Care	Multipurpose Solution - No Rub Care	Ciba Vision Aquify Multipurpose Solution	Total
Number of Participants [units: participants]	178	176	181	535
Age, Customized ^[1] [units: Participants]	178	176	181	535
Gender [units: participants]
Female	124	133	126	383
Male	54	43	55	152
Ethnicity (NIH/OMB) [units: participants]
Hispanic or Latino	10	4	7	21
Not Hispanic or Latino	168	172	174	514
Region of Enrollment [units: participants]
United States	178	176	181	535

[1]	Participants Aged 18-66

Outcome Measures

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1. Primary:

Slit-lamp Findings > Grade 2 [ Time Frame: Over 4 visits for 3 month period ]

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2. Primary:

Subjective Responses to Comfort Related Symptoms/Complaints [ Time Frame: Over 4 visits for the 3 month period ]

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3. Primary:

Contact Lens Deposits [ Time Frame: At each visit for 3 months ]

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Serious Adverse Events

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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: Robert Steffen
Organization: Bausch & Lomb
phone: (585) 338-6399
e-mail: robert.steffen@bausch.com

No publications provided

Responsible Party:	Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:	NCT00636363 History of Changes
Other Study ID Numbers:	554
Study First Received:	March 7, 2008
Results First Received:	February 3, 2011
Last Updated:	December 7, 2011
Health Authority:	United States: Food and Drug Administration

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