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Ocular Surface Immune Response in Dry Eye Disease

Sponsor
Tufts Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT02042820
Collaborator
(none)
67
Enrollment
1
Location
17.9
Duration (Months)
3.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: In vivo confocal microscopy (IVCM)

Study Design

Study Type:
Observational
Actual Enrollment :
67 participants
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
Study Start Date :
Jan 1, 2014
Actual Primary Completion Date :
Jul 1, 2015
Actual Study Completion Date :
Jul 1, 2015

Arms and Interventions

Arm Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

  1. Peripheral Corneal Immune cell Status by IVCM [Visit 1]

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

  2. Bulbar conjunctival immune cell Status by IVCM [Visit 1]

    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

  1. Clinical Parameter: Ocular Surface Disease Index (OSDI) [Visit 1]

  2. Clinical Parameter: Schirmer's II test [Visit 1]

  3. Clinical Parameter: Conjunctival staining with lissamine green [Visit 1]

  4. Clinical Parameter: Corneal staining with fluorescein [Visit 1]

  5. Clinical Parameter: Tear Break Up Time (TBUT) [Visit 1]

  6. Clinical Parameter: Conjunctival redness [Visit 1]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes

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

Locations

Site City State Country Postal Code
1 Massachusetts Eye and Ear Infirmary Boston Massachusetts United States 02114

Sponsors and Collaborators

  • Tufts Medical Center

Investigators

  • Principal Investigator: Pedram Hamrah, MD, MEEI

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Tufts Medical Center
ClinicalTrials.gov Identifier:
NCT02042820
Other Study ID Numbers:
  • 13-149H
First Posted:
Jan 23, 2014
Last Update Posted:
Oct 18, 2017
Last Verified:
Oct 1, 2017
Keywords provided by Tufts Medical Center
Dry Eye
Additional relevant MeSH terms:
Dry Eye Syndromes
Keratoconjunctivitis Sicca
Eye Diseases

Study Results

No Results Posted as of Oct 18, 2017