Evaluation of SYSTANE Ultra Lubricant Eye Drops

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Alcon Research

ClinicalTrials.gov Identifier:

NCT00702377

First received: June 19, 2008

Last updated: January 31, 2012

Last verified: January 2012

History of Changes

Results First Received: September 23, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Dry Eye
Interventions:	Other: SYSTANE Ultra Other: Optive

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
109 dry eye subjects

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Randomized, double-masked, parallel design

Reporting Groups

	Description
SYSTANE Ultra	SYSTANE Ultra Lubricant Eye Drops 1 drop each eye 4 times daily for 42 days
OPTIVE Lubricant Eye Drops	OPTIVE Lubricant Eye Drops 1 drop each eye 4 times daily for 42 days

Participant Flow: Overall Study

	SYSTANE Ultra	OPTIVE Lubricant Eye Drops
STARTED	53	56
COMPLETED	52	53
NOT COMPLETED	1	3

Baseline Characteristics

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Reporting Groups

	Description
SYSTANE Ultra	SYSTANE Ultra Lubricant Eye Drops 1 drop each eye 4 times daily for 42 days
OPTIVE Lubricant Eye Drops	OPTIVE Lubricant Eye Drops 1 drop each eye 4 times daily for 42 days
Total	Total of all reporting groups

Baseline Measures

	SYSTANE Ultra	OPTIVE Lubricant Eye Drops	Total
Number of Participants [units: participants]	53	56	109
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	34	43	77
>=65 years	19	13	32
Gender [units: participants]
Female	39	41	80
Male	14	15	29

Outcome Measures

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1. Primary:

Tear Break-up Time [ Time Frame: Day 0, Day 7, Day 14, Day 28, and Day 42 ]

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2. Primary:

Conjunctival Staining [ Time Frame: Day 0, Day 7, Day 14, Day 28, Day 42 ]

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3. Primary:

Corneal Staining [ Time Frame: Day 0, Day 7, Day 14, Day 28, Day 42 ]

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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 PI should hold confidential, and not disclose directly or indirectly to any third party other than Contractors, the data arising out of the study. Alcon reserves the right of prior review of any publication or presentation of information related to the study.

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: Alcon Clinical
Organization: Alcon Research Ltd
phone: 888.451.3937; 817.568.6725
e-mail: medinfo@alconlabs.com

No publications provided

Responsible Party:	Alcon Research
ClinicalTrials.gov Identifier:	NCT00702377 History of Changes
Other Study ID Numbers:	C-07-33
Study First Received:	June 19, 2008
Results First Received:	September 23, 2009
Last Updated:	January 31, 2012
Health Authority:	United States: Institutional Review Board

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