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

This study has been completed.
Sponsor:
Information provided by:
Alcon Research
ClinicalTrials.gov Identifier:
NCT00631358
First received: February 29, 2008
Last updated: March 29, 2010
Last verified: March 2010
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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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Maxidex Maxidex 1 drop in each eye 2 times daily
No Treatment Healthy normal control group receiving no treatment
Total Total of all reporting groups

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 ]

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

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

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

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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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  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:
unchecked 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.
unchecked 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.


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