Assessment of Inflammatory Biomarkers Expressed in a Sjogren's Population: Effect of a Topical Steroid Intervention

This study has been completed.

Study NCT00631358 Information provided by Alcon Research

First Received on February 29, 2008. Last Updated on March 29, 2010 History of Changes

Results First Received: February 17, 2010

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Sjogren's Syndrome
Interventions:	Drug: Maxidex Other: No treatment

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
Patients were recruited via flyers, newspaper advertisements, radio advertisements and chart review in the doctors’ office.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Maxidex	Maxidex 1 drop in each eye 2 times daily
No Treatment	Healthy normal control group receiving no treatment

Participant Flow: Overall Study

	Maxidex	No Treatment
STARTED	50	47
COMPLETED	44	45
NOT COMPLETED	6	2

Baseline Characteristics

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Reporting Groups

	Description
Maxidex	Maxidex 1 drop in each eye 2 times daily
No Treatment	Healthy normal control group receiving no treatment

Baseline Measures

	Maxidex	No Treatment	Total
Number of Participants [units: participants]	50	47	97
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	35	41	76
>=65 years	15	6	21
Gender [units: participants]
Female	48	43	91
Male	2	4	6

Outcome Measures

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1. Primary:

Change in Levels of Biomarkers After Dosing With Maxidex [ Time Frame: Baseline to 2 weeks ]

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2. Secondary:

Correlation Between Biomarker Expression and Ocular Symptoms [ Time Frame: Baseline to 2 weeks ]

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3. Secondary:

Correlation Between Biomarker Expression and Tear Film Break up Time [ Time Frame: Baseline to 2 weeks ]

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4. Secondary:

Correlation Between Biomarker Expression and NaFl (Sodium Fluorescein) Staining [ Time Frame: Baseline to 2 weeks ]

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5. Secondary:

Correlation Between Biomarker Expression and the Schirmer Test [ Time Frame: Baseline to 2 weeks ]

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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 sponsor shall be furnished with copies of any proposed disclosure as follows: Published abstracts will be submitted to the sponsor one month prior to submission allowing the sponsor three weeks to respond. Presentations will be submitted to the sponsor one moth prior to submission allowing the sponsor three weeks to respond. Publications will be submitted to the sponsor two months prior to submission allowing the sponsor two months to respond.

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
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Results Point of Contact:

Name/Title: Alcon Clinical
Organization: Alcon Labs
phone: 1-888-451-3937; 1-817-568-6725
e-mail: medinfo@alconlabs.com

No publications provided

Responsible Party:	Ravaughn Williams, OD, MS, Alcon
ClinicalTrials.gov Identifier:	NCT00631358 History of Changes
Obsolete Identifiers:	NCT00806702
Other Study ID Numbers:	ORE 14351
Study First Received:	February 29, 2008
Results First Received:	February 17, 2010
Last Updated:	March 29, 2010
Health Authority:	Canada: Health Canada; Canada: Institutional Ethics Committee