Phase 4
Completed N=97
Assessment of Inflammatory Biomarkers Expressed in a Sjogren's Population: Effect of a Topical Steroid Intervention
Source: ClinicalTrials.gov NCT00631358 ↗Enrolled (actual)
97
Serious AEs
0.0%
Results posted
Apr 2010
Primary outcomePrimary: Change in Levels of Biomarkers After Dosing With Maxidex — -1.244; -0.29; -0.033; -0.33 ddCt (Delta-Delta-Ct)
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Levels of Biomarkers After Dosing With Maxidex |
-1.244; -0.29; -0.033; -0.33 | — |
| SECONDARY Correlation Between Biomarker Expression and Ocular Symptoms |
-0.09; -0.10 | — |
| SECONDARY Correlation Between Biomarker Expression and Tear Film Break up Time |
-0.16; 0.12 | — |
| SECONDARY Correlation Between Biomarker Expression and NaFl (Sodium Fluorescein) Staining |
-0.05 | — |
| SECONDARY Correlation Between Biomarker Expression and the Schirmer Test |
-0.02; 0.07 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00631358). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.