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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00631358

Enrollment

Registered

2008-03-07

Start date

2008-02-29

Completion date

Unknown

Last updated

2010-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sjogren's Syndrome

Keywords

Ocular inflammation

Brief 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.

Interventions

DRUGMaxidex

Maxidex (0.1% Dexamethasone) 1 drop in each eye 2 times daily

OTHERNo treatment

Healthy normal control group receiving no treatment

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

17 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Change in Levels of Biomarkers After Dosing With Maxidex	Baseline to 2 weeks	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.

Secondary

Measure	Time frame	Description
Correlation Between Biomarker Expression and Ocular Symptoms	Baseline to 2 weeks	Correlation factor: tumor necrosis factor (TNF) messenger RNA (mRNA) vs. OSDI (Ocular Surface Disease Index).
Correlation Between Biomarker Expression and Tear Film Break up Time	Baseline to 2 weeks	Correlation factor: TNFmRNA vs. TFBUT (Tear Film Break-up Time)
Correlation Between Biomarker Expression and NaFl (Sodium Fluorescein) Staining	Baseline to 2 weeks	Correlation factor: TNFmRNA vs. NaFl staining
Correlation Between Biomarker Expression and the Schirmer Test	Baseline to 2 weeks	Correlation factor: TNFmRNA vs. Schirmer

Countries

Canada

Participant flow

Recruitment details

Patients were recruited via flyers, newspaper advertisements, radio advertisements and chart review in the doctors' office.

Participants by arm

Arm	Count
Maxidex Maxidex 1 drop in each eye 2 times daily	50
No Treatment Healthy normal control group receiving no treatment	47
Total	97

Baseline characteristics

Characteristic	Maxidex	No Treatment	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	15 Participants	6 Participants	21 Participants
Age, Categorical Between 18 and 65 years	35 Participants	41 Participants	76 Participants
Sex: Female, Male Female	48 Participants	43 Participants	91 Participants
Sex: Female, Male Male	2 Participants	4 Participants	6 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	0 / 50	0 / 47
serious Total, serious adverse events	0 / 50	0 / 47

Outcome results

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.