Sjogren's SyndromePhase 4NCT00631358
Assessment of Inflammatory Biomarkers Expressed in a Sjogren's Population: Effect of a Topical Steroid Intervention
A Phase 4 study testing Maxidex and No treatment in people with Sjogren's Syndrome, run by Alcon Research at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 17 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sjogren's Syndrome
- What is being tested?
- Maxidex and No treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 97 participants
- Where
- 2 sitesCanada
- Study dates
- Feb 2008to Feb 2009
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 17 years or older
- LogMar visual acuity of 0.6 or better
- Ocular inflammation associated with Sjogren's Syndrome
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
About this study
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.
- Conditions
- Sjogren's Syndrome
- Being tested
- Maxidex, No treatment
- Keywords
- Ocular inflammation
- Medical subject headings
- Sjogren's Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MaxidexDrug
Maxidex (0.1% Dexamethasone) 1 drop in each eye 2 times daily
No treatmentOther
Healthy normal control group receiving no treatment
| Study group | Role | What they receive |
|---|---|---|
| Maxidex | Experimental | Maxidex Receives: Drug: Maxidex |
| No treatment | Sham comparator | Healthy normal control group receiving no treatment Receives: Other: No treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 2 weeks
Secondary outcomes (4)
Correlation Between Biomarker Expression and Ocular Symptoms
Correlation factor: tumor necrosis factor (TNF) messenger RNA (mRNA) vs. OSDI (Ocular Surface Disease Index).
Measured: Baseline to 2 weeks
Correlation Between Biomarker Expression and Tear Film Break up Time
Correlation factor:
TNFmRNA vs. TFBUT (Tear Film Break-up Time)
Measured: Baseline to 2 weeks
Correlation Between Biomarker Expression and NaFl (Sodium Fluorescein) Staining
Correlation factor:
TNFmRNA vs. NaFl staining
Measured: Baseline to 2 weeks
Correlation Between Biomarker Expression and the Schirmer Test
Correlation factor: TNFmRNA vs. Schirmer
Measured: Baseline to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2008 (estimated)
- Study startFeb 2008
- Primary completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Sjogren's SyndromeStudies of the same condition, open and under way.
- More trials run by Alcon ResearchThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00631358
- Sponsor's protocol ID
- ORE 14351
- Status last verified
- Mar 2010
- First submitted
- 29 Feb 2008
- Last updated
- 12 Apr 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Inflammatory Biomarkers Expressed in a Sjogren's Population: Effect of a Topical Steroid Intervention
- ClinicalTrials.gov ID
- NCT00631358
- Acronym / sponsor ID
- ORE 14351
- Conditions
- Sjogren's Syndrome
- Keywords
- Ocular inflammation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Feb 2008
- Primary completion
- Feb 2009 (actual)
- First posted
- 7 Mar 2008 (estimated)
- Results
- Posted 12 Apr 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Maxidex | Experimental | Drug: MaxidexMaxidex |
| No treatment | Sham comparator | Other: No treatmentHealthy normal control group receiving no treatment |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 17 years or older
- LogMar visual acuity of 0.6 or better
- Ocular inflammation associated with Sjogren's Syndrome
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MaxidexMaxidex (0.1% Dexamethasone) 1 drop in each eye 2 times daily | Drug | Maxidex |
| No treatmentHealthy normal control group receiving no treatment | Other | No treatment |
Primary outcome
Change in Levels of Biomarkers After Dosing With Maxidex
Time frame: 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.
4 secondary outcomes
Correlation Between Biomarker Expression and Ocular Symptoms
Time frame: Baseline to 2 weeks
Correlation Between Biomarker Expression and Tear Film Break up Time
Time frame: Baseline to 2 weeks
Correlation Between Biomarker Expression and NaFl (Sodium Fluorescein) Staining
Time frame: Baseline to 2 weeks
Correlation Between Biomarker Expression and the Schirmer Test
Time frame: Baseline to 2 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Maxidex and No treatment in people with Sjogren's Syndrome, run by Alcon Research at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Apr 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Levels of Biomarkers After Dosing With Maxidex (time frame: Baseline to 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2010.