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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT00631358 |
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Date of registration:
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29/02/2008 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Assessment of Inflammatory Biomarkers Expressed in a Sjogren's Population: Effect of a Topical Steroid Intervention
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Scientific title:
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Date of first enrolment:
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February 2008 |
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Target sample size:
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97 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00631358 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 4
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Countries of recruitment
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Canada
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Key inclusion & exclusion criteria
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Inclusion Criteria of Sjorgren's Population:
Inclusion Criteria:
- 17 years or older
- LogMar visual acuity of 0.6 or better
- Ocular inflammation associated with Sjogren's Syndrome
Exclusion Criteria:
- Has had an adverse reaction to either topical of systemic steroids in the past
- Has diabetes (type 1 or 2)
- Has glaucoma or evidence of ocular hypertension in either eye or treatment of either
within six months of Visit 1
- Has worn contact lenses within one week prior to Visit 1
- Has received ocular prescription therapy in the last 30 days
- Has active ocular infections or inflammation not associated with Sjogren's Syndrome.
- Has any finding in the vitreous, macula, retina or choroid that show signs of
inflammation and/or any structural change that in the opinion of the investigator is
considered abnormal or unstable for that participant
Age minimum:
17 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Sjogren's Syndrome
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Intervention(s)
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Other: No treatment
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Drug: Maxidex
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Primary Outcome(s)
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Change in Levels of Biomarkers After Dosing With Maxidex
[Time Frame: Baseline to 2 weeks]
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Secondary Outcome(s)
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Correlation Between Biomarker Expression and Ocular Symptoms
[Time Frame: Baseline to 2 weeks]
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Correlation Between Biomarker Expression and NaFl (Sodium Fluorescein) Staining
[Time Frame: Baseline to 2 weeks]
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Correlation Between Biomarker Expression and the Schirmer Test
[Time Frame: Baseline to 2 weeks]
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Correlation Between Biomarker Expression and Tear Film Break up Time
[Time Frame: Baseline to 2 weeks]
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Secondary ID(s)
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ORE 14351
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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