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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

97 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Brief Summary

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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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Detailed Description

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Conditions

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Sjogren's Syndrome

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Maxidex

Group Type EXPERIMENTAL

Maxidex

Intervention Type DRUG

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

No treatment

Healthy normal control group receiving no treatment

Group Type SHAM_COMPARATOR

No treatment

Intervention Type OTHER

Healthy normal control group receiving no treatment

Interventions

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Maxidex

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

Intervention Type DRUG

No treatment

Healthy normal control group receiving no treatment

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes