NCT02322528

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

April 16, 2014

Completed
8 months until next milestone

First Posted

Study publicly available on registry

December 23, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
3 months until next milestone

Results Posted

Study results publicly available

October 16, 2015

Completed
Last Updated

October 16, 2015

Status Verified

September 1, 2015

Enrollment Period

1.3 years

First QC Date

April 16, 2014

Results QC Date

September 17, 2015

Last Update Submit

September 17, 2015

Conditions

Sjogren's Disease

Keywords

Non-invasive instrumentsEnvironmentWavefrontPlacido DiskEllipsometerThermal Imaging

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    baseline, 30 minutes, week 1, week 2

Study Arms (1)

Administration of Lotemax

OTHER

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

Drug: Administration of Lotemax

Interventions

Administration of LotemaxDRUG

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

Administration of Lotemax

Eligibility Criteria

Age50 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Flaum Eye Institute at the University of Rochester

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Sjogren's Syndrome

Condition Hierarchy (Ancestors)

Arthritis, RheumatoidArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesXerostomiaSalivary Gland DiseasesMouth DiseasesStomatognathic DiseasesDry Eye SyndromesLacrimal Apparatus DiseasesEye DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Results Point of Contact

Title
Dr. James V. Aquavella
Organization
University of Rochester
rick_barrett@urmc.rochester.edu
585-276-7439

Study Officials

  • James V Aquavella, MD

    University of Rochester

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 16, 2014

First Posted

December 23, 2014

Study Start

April 1, 2014

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

October 16, 2015

Results First Posted

October 16, 2015

Record last verified: 2015-09

Locations

US(1)