NCT02042820

Brief Summary

In vivo confocal microscopy (IVCM) is a sensitive imaging tool for detecting dry eye-associated subclinical inflammation. Studies have previously shown that IVCM provides an in vivo metric to measure inflammatory changes in the central cornea. The objective of the current study is to assess inflammatory response changes in the peripheral cornea and the conjunctiva by analyzing epithelial immune cell density and morphology in these areas and then correlating the IVCM findings to clinical signs and symptoms to establish novel objective imaging biomarkers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
67

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

January 17, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 23, 2014

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

October 18, 2017

Status Verified

October 1, 2017

Enrollment Period

1.5 years

First QC Date

January 17, 2014

Last Update Submit

October 16, 2017

Conditions

Dry Eye Disease

Keywords

Dry Eye

Outcome Measures

Primary Outcomes (2)

  • Peripheral Corneal Immune cell Status by IVCM

    Peripheral Corneal Immune cell Status by IVCM • Density of dendritic immune cells • Density of non-dendritic immune cells • Morphology of immune cells

    Visit 1

  • Bulbar conjunctival immune cell Status by IVCM

    Bulbar conjunctival immune cell Status by IVCM • Density of dendritic immune cells • Density of non-dendritic immune cells • Morphology of immune cells

    Visit 1

Secondary Outcomes (6)

  • Clinical Parameter: Ocular Surface Disease Index (OSDI)

    Visit 1

  • Clinical Parameter: Schirmer's II test

    Visit 1

  • Clinical Parameter: Conjunctival staining with lissamine green

    Visit 1

  • Clinical Parameter: Corneal staining with fluorescein

    Visit 1

  • Clinical Parameter: Tear Break Up Time (TBUT)

    Visit 1

  • +1 more secondary outcomes

Study Arms (2)

Dry Eye Disease

Confocal Imaging - In vivo confocal microscopy (IVCM) Ophthalmic Examination: * Tear Break Up Time (TBUT) * Ocular Surface Disease Index (OSDI) * Schirmer's II test * Conjunctival staining with lissamine green * Corneal staining with fluorescein * Conjunctival redness assessment

Other: In vivo confocal microscopy (IVCM)

Control

Confocal Imaging - In vivo confocal microscopy (IVCM) Ophthalmic Examination: * TBUT * OSDI * Schirmer's II test * Conjunctival staining with lissamine green * Corneal staining with fluorescein * Conjunctival redness assessment

Other: In vivo confocal microscopy (IVCM)

Interventions

In vivo confocal microscopy (IVCM)OTHER

IVCM is a sensitive tool for detecting dry eye-associated subclinical inflammation.

ControlDry Eye Disease

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with and without Dry Eye Disease

You may qualify if:

  • Age \>18
  • Ability to consent to study
  • Symptoms of dry eye disease for at least 6 months, such foreign body sensation, burning, stinging, light sensitivity
  • Positive vital dye staining of the cornea
  • At least one of the following objective signs: (Schirmer I \<10 mm at 5 minutes), decreased (\<0.2 mm) tear meniscus, decreased tear breakup time (TBUT) of \<10 seconds, positive vital dye staining of the conjunctiva
  • For Age-Match Controls
  • Between the ages of 18-89
  • Clear, healthy cornea
  • Normal tear meniscus (\> 0.3 mm)
  • For Dry Eye Disease Participants

You may not qualify if:

  • History of contact lens wear in the past 3 months
  • History of ocular surgery in the past 6 months
  • Active ocular allergies
  • History of ocular infection in the past 3 months
  • History of diabetes
  • History of topical or systemic anti-inflammatory therapy in the past 1 month
  • For Age-Match Controls
  • History of ocular or eyelid surgery within the past 12 months
  • History of herpetic or other infectious keratitis or other inflammatory eye disease
  • History of any other acute ocular disease
  • Current use of topical medications (not including artificial tears)
  • Current use of contact lenses
  • History of ocular carcinoma or any recent ocular topical chemotherapy or radiotherapy
  • History of cancer elsewhere in the body which is currently under systemic chemotherapy
  • Current glaucoma disease requiring use of glaucoma drops
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts Eye and Ear Infirmary

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Study Officials

  • Pedram Hamrah, MD

    MEEI

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2014

First Posted

January 23, 2014

Study Start

January 1, 2014

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

October 18, 2017

Record last verified: 2017-10

Locations

US(1)