Trial Outcomes & Findings for Assessment of Inflammatory Biomarkers Expressed in a Sjogren's Population: Effect of a Topical Steroid Intervention (NCT NCT00631358)

NCT ID: NCT00631358

Last Updated: 2010-04-12

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

97 participants

Primary outcome timeframe

Baseline to 2 weeks

Results posted on

2010-04-12

Participant Flow

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

Participant milestones

Participant milestones
Measure	Maxidex Maxidex 1 drop in each eye 2 times daily	No Treatment Healthy normal control group receiving no treatment
Overall Study STARTED	50	47
Overall Study COMPLETED	44	45
Overall Study NOT COMPLETED	6	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Maxidex n=50 Participants Maxidex 1 drop in each eye 2 times daily	No Treatment n=47 Participants Healthy normal control group receiving no treatment	Total n=97 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	35 Participants n=5 Participants	41 Participants n=7 Participants	76 Participants n=5 Participants
Age, Categorical >=65 years	15 Participants n=5 Participants	6 Participants n=7 Participants	21 Participants n=5 Participants
Sex: Female, Male Female	48 Participants n=5 Participants	43 Participants n=7 Participants	91 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Maxidex n=50 Participants Maxidex 1 drop in each eye 2 times daily	No Treatment n=47 Participants Healthy normal control group receiving no treatment
Change in Levels of Biomarkers After Dosing With Maxidex Baseline	-1.244 ddCt (Delta-Delta-Ct) Standard Deviation 1.08	-0.29 ddCt (Delta-Delta-Ct) Standard Deviation 0.88
Change in Levels of Biomarkers After Dosing With Maxidex 2 weeks	-0.033 ddCt (Delta-Delta-Ct) Standard Deviation 1.06	-0.33 ddCt (Delta-Delta-Ct) Standard Deviation 0.85

SECONDARY outcome

Timeframe: Baseline to 2 weeks

Correlation factor: tumor necrosis factor (TNF) messenger RNA (mRNA) vs. OSDI (Ocular Surface Disease Index).

Outcome measures

Outcome measures
Measure	Maxidex n=50 Participants Maxidex 1 drop in each eye 2 times daily	No Treatment n=47 Participants Healthy normal control group receiving no treatment
Correlation Between Biomarker Expression and Ocular Symptoms	-0.09 Correlation factor	-0.10 Correlation factor

SECONDARY outcome

Timeframe: Baseline to 2 weeks

Correlation factor: TNFmRNA vs. TFBUT (Tear Film Break-up Time)

Outcome measures

Outcome measures
Measure	Maxidex n=50 Participants Maxidex 1 drop in each eye 2 times daily	No Treatment n=47 Participants Healthy normal control group receiving no treatment
Correlation Between Biomarker Expression and Tear Film Break up Time	-0.16 Correlation factor	0.12 Correlation factor

SECONDARY outcome

Timeframe: Baseline to 2 weeks

Population: No data available for the no treatment group.

Correlation factor: TNFmRNA vs. NaFl staining

Outcome measures

Outcome measures
Measure	Maxidex n=50 Participants Maxidex 1 drop in each eye 2 times daily	No Treatment Healthy normal control group receiving no treatment
Correlation Between Biomarker Expression and NaFl (Sodium Fluorescein) Staining	-0.05 Correlation factor	—

SECONDARY outcome

Timeframe: Baseline to 2 weeks

Correlation factor: TNFmRNA vs. Schirmer

Outcome measures

Outcome measures
Measure	Maxidex n=50 Participants Maxidex 1 drop in each eye 2 times daily	No Treatment n=47 Participants Healthy normal control group receiving no treatment
Correlation Between Biomarker Expression and the Schirmer Test	-0.02 Correlation Factor	0.07 Correlation Factor

Adverse Events

Maxidex

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

No Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Alcon Clinical

Alcon Labs

Phone: 1-888-451-3937; 1-817-568-6725

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER