CompletedNCT02322528Updated Oct 16, 2015Results posted

Evaluation of Ocular Surface Inflammatory Mediators Effected by Lotemax

An interventional study of Administration of Lotemax in Sjogren's Disease, sponsored by University of Rochester. Completed at 1 site in United States. Open to participants aged 50 Years to 70 Years. Per ClinicalTrials.gov, last updated 2015-10-16.

Sponsored by University of Rochester · Not applicable, Interventional, and Diagnostic

Phase: Not applicable
Study type: Interventional
Enrollment: 10
Allocation: Not applicable
Ages: 50 Years to 70 Years
Sex: All

Study 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).

Conditions studied

Sjogren's Disease

Browse trials for

Sjogren's Syndrome 381

Keywords

Non-invasive instruments
Environment
Wavefront
Placido Disk
Ellipsometer
Thermal Imaging

In context

Sjogren's Syndrome

381 studies on the registry are indexed under Sjogren's Syndrome; 106 are open to participants now.

This study's enrollment of 10 is below the median of 50 across 250 interventional studies indexed under Sjogren's Syndrome.

Browse Sjogren's Syndrome studies →

Lead sponsor

University of Rochester is the lead sponsor of 728 studies on the registry; 115 are open to participants now.

Of its 56 completed or terminated interventional studies of FDA-regulated products, 44 (79%) have results posted.

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Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 50 Years to 70 Years
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

EXCLUSION CRITERIA:

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

Study design

Phase: Not applicable
Primary purpose: Diagnostic
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 10 participants (actual)

Study arms

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

Interventions

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

What researchers measure

Primary outcomes

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.
Time frame: 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.
Time frame: baseline, 30 minutes, week 1, week 2

Results

Posted Oct 16, 2015

Participant flow

Participant flow — Overall Study
Milestone	Administration of 0.5% Lotemax
Started	10
Completed	10
Not completed	0

Outcome measures

PrimaryOcular 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.

Time frame:: baseline, 30 minutes, week 1, week 2
Reported as:: Mean · degrees celcius

Ocular Surface Temperature of Both Eyes
degrees celcius	Administration of 0.5% Lotemax
baseline	33.95 ± 0.13
30 minutes	34.3 ± 0.13
week 1	33.93 ± 0.12
week 2	33.95 ± 0.13

PrimaryVisual Quality

Using a Shack Hartmann wavefront sensor, measured root mean square of wavefront aberrations caused by dynamic tear film changes.

Time frame:: baseline, 30 minutes, week 1, week 2
Reported as:: Mean · microns

Visual Quality
microns	Administration of 0.5% Lotemax
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

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Administration of 0.5% Lotemax	—	0/10 (0%)	0/10 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Administration of Lotemax
Mean	56.7 ± 4.92

Sex: Female, Male
Sex: Female, Male(Participants)	Administration of Lotemax
Female	9
Male	1

Region of Enrollment
Region of Enrollment(participants)	Administration of Lotemax
United States	10

Study locations

1 site

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

Timeline

Tracking since Sep 25, 2026

Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Apr 2014, a primary completion of Aug 2015 and a completion of Aug 2015. It does not say whether these dates are actual or estimated.

Results were first posted in Oct 2015, 2 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered: Apr 16, 2014
First posted: Dec 23, 2014
Start: Apr 2014
Primary completionActual: Aug 2015
CompletionActual: Aug 2015
Results first posted: Oct 16, 2015
Last update: Oct 16, 2015

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Oct 16, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02322528
Lead sponsor: University of Rochester
Collaborators: Bausch & Lomb Incorporated
Responsible party: James V. Aquavella, MD (Principal Investigator, University of Rochester) — Principal investigator
First posted: Dec 23, 2014
Start date: Apr 2014
Primary completion: Aug 2015
Completion: Aug 2015
Results posted: Oct 16, 2015
Last update: Oct 16, 2015

Study contacts

James V Aquavella, MD

principal investigator · University of Rochester

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.

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