Phase 4
N=97
Assessment of Inflammatory Biomarkers Expressed in a Sjogren's Population: Effect of a Topical Steroid Intervention
Sjogren's Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT00631358 ↗Enrolled (actual)
97
Serious AEs
0.0%
Results posted
Apr 2010
Primary outcome: Primary: Change in Levels of Biomarkers After Dosing With Maxidex — -1.244; -0.29; -0.033; -0.33 ddCt (Delta-Delta-Ct)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Maxidex (Drug); No treatment (Other)
- Age
- Pediatric, Adult, Older Adult · 17+ yrs
- Sex
- All
- Sponsor
- Alcon Research
- Primary completion
- Feb 2009
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 | — |
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.
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.