Ocular Surface Immune Response in Dry Eye Disease: Analysis of Conjunctival and Peripheral Corneal Immune Cell Alterations by In Vivo Confocal Microscopy and Clinical Correlation

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Massachusetts Eye and Ear Infirmary
Sponsor:
Information provided by (Responsible Party):
Massachusetts Eye and Ear Infirmary
ClinicalTrials.gov Identifier:
NCT02042820
First received: January 17, 2014
Last updated: January 20, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Dry Eye Disease
Other: In vivo confocal microscopy (IVCM)

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Ocular Surface Immune Response in Dry Eye Disease: Analysis of Conjunctival and Peripheral Corneal Immune Cell Alterations by In Vivo Confocal Microscopy and Clinical Correlation

Resource links provided by NLM:


Further study details as provided by Massachusetts Eye and Ear Infirmary:

Primary Outcome Measures:
  • Peripheral Corneal Immune cell Status by IVCM [ Time Frame: Visit 1 ] [ Designated as safety issue: No ]
    Peripheral Corneal Immune cell Status by IVCM • Density of dendritic immune cells • Density of non-dendritic immune cells • Morphology of immune cells

  • Bulbar conjunctival immune cell Status by IVCM [ Time Frame: Visit 1 ] [ Designated as safety issue: No ]
    Bulbar conjunctival immune cell Status by IVCM • Density of dendritic immune cells • Density of non-dendritic immune cells • Morphology of immune cells


Secondary Outcome Measures:
  • Clinical Parameter: Ocular Surface Disease Index (OSDI) [ Time Frame: Visit 1 ] [ Designated as safety issue: No ]
  • Clinical Parameter: Schirmer's II test [ Time Frame: Visit 1 ] [ Designated as safety issue: No ]
  • Clinical Parameter: Conjunctival staining with lissamine green [ Time Frame: Visit 1 ] [ Designated as safety issue: No ]
  • Clinical Parameter: Corneal staining with fluorescein [ Time Frame: Visit 1 ] [ Designated as safety issue: No ]
  • Clinical Parameter: Tear Break Up Time (TBUT) [ Time Frame: Visit 1 ] [ Designated as safety issue: No ]
  • Clinical Parameter: Conjunctival redness [ Time Frame: Visit 1 ] [ Designated as safety issue: No ]

Estimated Enrollment: 75
Study Start Date: January 2014
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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)
IVCM is a sensitive tool for detecting dry eye-associated subclinical inflammation.
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)
IVCM is a sensitive tool for detecting dry eye-associated subclinical inflammation.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Patients with and without Dry Eye Disease

Criteria

For Dry Eye Disease Participants

Inclusion Criteria:

  • 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

Inclusion Criteria:

  • Between the ages of 18-89
  • The ability to provide informed consent for study inclusion
  • Clear, healthy cornea
  • Normal tear meniscus (> 0.3 mm)

For Dry Eye Disease Participants

Exclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • History of Diabetes mellitus
  • Current diagnosis of dry eye disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02042820

Contacts
Contact: Cornea Research 617-573-3313 Cornea_Research@meei.harvard.edu

Locations
United States, Massachusetts
Massachusetts Eye and Ear Infirmary Recruiting
Boston, Massachusetts, United States, 02114
Contact: Cornea Research    617-573-3313    Cornea_Research@meei.harvard.edu   
Principal Investigator: Pedram Hamrah, MD         
Sponsors and Collaborators
Massachusetts Eye and Ear Infirmary
Investigators
Principal Investigator: Pedram Hamrah, MD MEEI
  More Information

No publications provided

Responsible Party: Massachusetts Eye and Ear Infirmary
ClinicalTrials.gov Identifier: NCT02042820     History of Changes
Other Study ID Numbers: 13-149H
Study First Received: January 17, 2014
Last Updated: January 20, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts Eye and Ear Infirmary:
Dry Eye

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Eye Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases

ClinicalTrials.gov processed this record on September 16, 2014