Sjogren's DiseaseNCT02322528

Evaluation of Ocular Surface Inflammatory Mediators Effected by Lotemax

A study testing Administration of Lotemax in people with Sjogren's Disease, run by University of Rochester at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to evaluate the effects of an anti-inflammatory drug (Lotemax®) on the surface of the eye and tear film (a film that coats the eye which is made up of oil and water). Read more about this study

Who is it for?: Ages 50 to 70 years
Conditions the study is for: Sjogren's Disease
What is being tested?: Administration of Lotemax
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: 1 siteUnited States
Study dates: Apr 2014to Aug 2015
Phase: Interventional
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 50 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age 50-70
Diagnosed with Sjogren's Disease
Good general health (defined by medication use that has not changed within the last 2 months and the absence of medical conditions that are deemed confounding to the data as determined by the PI)
Ability to give informed consent
Willing to spend time for the study; approximately one hour for a screening visit and between 60-90 minutes for each of the measurement visits
Either gender
Any racial or ethnic origin

Who cannot join

Use of any prescription ocular medication (such as but not limited to, glaucoma medications and Restasis) used within 14 days of the screening visit or started prior to the measurement visit(s).
Current acute eye disease that affects the surface of the eye such as, but not limited to blepharitis, ocular allergy, and infection.
Subjects who have had cataract surgery less than one year ago
Use of soft or hard contact lenses.
Female subjects may not be pregnant or lactating (subjects will be asked to self-report these conditions).
Inability to provide analyzable data

Trial locations and contacts

1 site in 1 country.

United States1 site

Flaum Eye Institute at the University of Rochester
Rochester, New York, 14642

Other trials in United States

About this study

Official title: Evaluation of Ocular Surface Inflammatory Mediators and Ocular Surface Metrology Effected by Lotemax

The purpose of this study is to evaluate the effects of an anti-inflammatory drug (Lotemax®) on the surface of the eye and tear film (a film that coats the eye which is made up of oil and water).

Conditions: Sjogren's Disease
Being tested: Administration of Lotemax
Keywords: Non-invasive instruments, Environment, Wavefront, Placido Disk, Ellipsometer, Thermal Imaging
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.

Administration of LotemaxDrug
An FDA approved drug (Lotemax) will be administered to induce an inflammatory mediated response in both eyes.

Study groups in NCT02322528
Study group	Role	What they receive
Administration of Lotemax	Other	An FDA approved drug (Lotemax) will be administered to both eyes to induce an inflammatory mediated response. Receives: Drug: Administration of Lotemax

What is being measured

The primary outcome is the main question the study is designed to answer.

Ocular Surface Temperature of Both Eyes
Lotemax® is an FDA-approved ophthalmic suspension for the treatment of steroid-responsive inflammatory conditions which include dry eye associated ocular surface inflammation. Lotemax® will serve as a vehicle to study the changes in the inflammatory mediators on the surface of the eye as well as collect the inflammatory mediators for laboratory analysis, utilizing Luminex instrumentation and standard ELISA assays.
Measured: baseline, 30 minutes, week 1, week 2
Visual Quality
Using a Shack Hartmann wavefront sensor, measured root mean square of wavefront aberrations caused by dynamic tear film changes.
Measured: baseline, 30 minutes, week 1, week 2

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2014Aug 2015

First posted23 Dec 2014 (estimated)
Study startApr 2014
Primary completionAug 2015
Study completionAug 2015

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 DiseaseStudies of the same condition, open and under way.
More trials run by University of RochesterThe 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 N/A
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02322528
Sponsor's protocol ID: 47817
Status last verified: Sep 2015
First submitted: 16 Apr 2014
Last updated: 16 Oct 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Sjogren's Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Ocular Surface Inflammatory Mediators and Ocular Surface Metrology Effected by Lotemax
ClinicalTrials.gov ID: NCT02322528
Acronym / sponsor ID: 47817
Conditions: Sjogren's Disease
Keywords: Non-invasive instruments, Environment, Wavefront, Placido Disk, Ellipsometer, Thermal Imaging
Study type: Interventional
Recruitment status: Completed
Enrolment: 10 participants (actual)
Lead sponsor: University of RochesterUniversity, hospital or other
Collaborators: Bausch & Lomb Incorporated
Study start: Apr 2014
Primary completion: Aug 2015 (actual)
Study completion: Aug 2015 (actual)
First posted: 23 Dec 2014 (estimated)
Results: Posted 16 Oct 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to evaluate the effects of an anti-inflammatory drug (Lotemax®) on the surface of the eye and tear film (a film that coats the eye which is made up of oil and water).

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Administration of Lotemax	Other	Drug: Administration of LotemaxAn FDA approved drug (Lotemax) will be administered to both eyes to induce an inflammatory mediated response.

Who may qualify

Ages: 50 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Age 50-70
Diagnosed with Sjogren's Disease
Good general health (defined by medication use that has not changed within the last 2 months and the absence of medical conditions that are deemed confounding to the data as determined by the PI)
Ability to give informed consent
Willing to spend time for the study; approximately one hour for a screening visit and between 60-90 minutes for each of the measurement visits

Key exclusion criteria (6 listed)

Use of any prescription ocular medication (such as but not limited to, glaucoma medications and Restasis) used within 14 days of the screening visit or started prior to the measurement visit(s).
Current acute eye disease that affects the surface of the eye such as, but not limited to blepharitis, ocular allergy, and infection.
Subjects who have had cataract surgery less than one year ago
Use of soft or hard contact lenses.
Female subjects may not be pregnant or lactating (subjects will be asked to self-report these conditions).

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
Administration of LotemaxAn FDA approved drug (Lotemax) will be administered to induce an inflammatory mediated response in both eyes.	Drug	Administration of Lotemax

Primary outcome

Ocular Surface Temperature of Both Eyes
Time frame: baseline, 30 minutes, week 1, week 2
Lotemax® is an FDA-approved ophthalmic suspension for the treatment of steroid-responsive inflammatory conditions which include dry eye associated ocular surface inflammation. Lotemax® will serve as a vehicle to study the changes in the inflammatory mediators on the surface of the eye as well as collect the inflammatory mediators for laboratory analysis, utilizing Luminex instrumentation and standard ELISA assays.
Visual Quality
Time frame: baseline, 30 minutes, week 1, week 2
Using a Shack Hartmann wavefront sensor, measured root mean square of wavefront aberrations caused by dynamic tear film changes.

Results and safety

Results posted to the registry on 16 Oct 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Administration of 0.5% Lotemax	10	10

Primary outcome: Ocular Surface Temperature of Both Eyes

Time frame: baseline, 30 minutes, week 1, week 2. Mean (Standard Deviation). Unit: degrees celcius

Measure	Administration of 0.5% Lotemax n = 10
baseline	33.95 (0.13)
30 minutes	34.3 (0.13)
week 1	33.93 (0.12)
week 2	33.95 (0.13)

Primary outcome: Visual Quality

Time frame: baseline, 30 minutes, week 1, week 2. Mean (Standard Deviation). Unit: microns

Measure	Administration of 0.5% Lotemax n = 10
baseline	0.48 (0.04)
30 minutes	0.54 (0.04)
week 1	0.49 (0.08)
week 2	0.48 (0.04)

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Administration of 0.5% Lotemax	0 of 10 (0%)	0 of 10 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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RecruitingPhase 1
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RecruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
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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.

James V Aquavella, MD principal investigator

University of Rochester

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Administration of Lotemax in people with Sjogren's Disease, run by University of Rochester at 1 site in United States.

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 7 inclusion and 6 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 16 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Oct 2015). 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?

Ocular Surface Temperature of Both Eyes (time frame: baseline, 30 minutes, week 1, week 2). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02322528.

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 16 Oct 2015.