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The primary purpose of this study is to quantify the change in expression of biomarkers on the ocular surface of Sjogren's Syndrome participants after treatment with Maxidex.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Maxidex | Experimental | Maxidex |
|
| No treatment | Sham Comparator | Healthy normal control group receiving no treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Maxidex | Drug | Maxidex (0.1% Dexamethasone) 1 drop in each eye 2 times daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Levels of Biomarkers After Dosing With Maxidex | Biomarkers are an indicatior of inflammation. In this study, the level of biomarkers before and after anti-inflammatory treatment (Maxidex) is measured for the treatment group. In the control group, the biomarker level is measured at baseline and 2 weeks later. ddCt (Delta-Delta-Ct) is the number of polymerase chain reaction (PCR) cycles required to generate a quantifiable number. | Baseline to 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation Between Biomarker Expression and Ocular Symptoms | Correlation factor: tumor necrosis factor (TNF) messenger RNA (mRNA) vs. OSDI (Ocular Surface Disease Index). | Baseline to 2 weeks |
| Correlation Between Biomarker Expression and Tear Film Break up Time |
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Inclusion Criteria of Sjorgren's Population:
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Toronto | Toronto | Canada | ||||
| Waterloo |
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Patients were recruited via flyers, newspaper advertisements, radio advertisements and chart review in the doctors' office.
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| ID | Title | Description |
|---|---|---|
| FG000 | Maxidex | Maxidex 1 drop in each eye 2 times daily |
| FG001 | No Treatment | Healthy normal control group receiving no treatment |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Maxidex | Maxidex 1 drop in each eye 2 times daily |
| BG001 | No Treatment | Healthy normal control group receiving no treatment |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Levels of Biomarkers After Dosing With Maxidex | Biomarkers are an indicatior of inflammation. In this study, the level of biomarkers before and after anti-inflammatory treatment (Maxidex) is measured for the treatment group. In the control group, the biomarker level is measured at baseline and 2 weeks later. ddCt (Delta-Delta-Ct) is the number of polymerase chain reaction (PCR) cycles required to generate a quantifiable number. | Posted | Mean | Standard Deviation | ddCt (Delta-Delta-Ct) | Baseline to 2 weeks |
|
Adverse reporting began once the patient enrolled into the study and went on for the duration of the study (6 weeks).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Maxidex | Maxidex 1 drop in each eye 2 times daily |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alcon Clinical | Alcon Labs | 1-888-451-3937; 1-817-568-6725 | medinfo@alconlabs.com |
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| ID | Term |
|---|---|
| D012859 | Sjogren's Syndrome |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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| No treatment |
| Other |
Healthy normal control group receiving no treatment |
|
Correlation factor: TNFmRNA vs. TFBUT (Tear Film Break-up Time) |
| Baseline to 2 weeks |
| Correlation Between Biomarker Expression and NaFl (Sodium Fluorescein) Staining | Correlation factor: TNFmRNA vs. NaFl staining | Baseline to 2 weeks |
| Correlation Between Biomarker Expression and the Schirmer Test | Correlation factor: TNFmRNA vs. Schirmer | Baseline to 2 weeks |
| Waterloo |
| Canada |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | Correlation Between Biomarker Expression and Ocular Symptoms | Correlation factor: tumor necrosis factor (TNF) messenger RNA (mRNA) vs. OSDI (Ocular Surface Disease Index). | Posted | Number | Correlation factor | Baseline to 2 weeks |
|
|
|
| Secondary | Correlation Between Biomarker Expression and Tear Film Break up Time | Correlation factor: TNFmRNA vs. TFBUT (Tear Film Break-up Time) | Posted | Number | Correlation factor | Baseline to 2 weeks |
|
|
|
| Secondary | Correlation Between Biomarker Expression and NaFl (Sodium Fluorescein) Staining | Correlation factor: TNFmRNA vs. NaFl staining | No data available for the no treatment group. | Posted | Number | Correlation factor | Baseline to 2 weeks |
|
|
|
| Secondary | Correlation Between Biomarker Expression and the Schirmer Test | Correlation factor: TNFmRNA vs. Schirmer | Posted | Number | Correlation Factor | Baseline to 2 weeks |
|
|
|
| 0 |
| 50 |
| 0 |
| 50 |
| EG001 | No Treatment | Healthy normal control group receiving no treatment | 0 | 47 | 0 | 47 |
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.
| D012216 |
| Rheumatic Diseases |
| D014987 | Xerostomia |
| D012466 | Salivary Gland Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D015352 | Dry Eye Syndromes |
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |