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Completed

NCT Number: NCT02042820

Ocular Surface Immune Response in Dry Eye Disease

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Massachusetts Eye and Ear Infirmary

Boston, Massachusetts, 02114, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

In vivo confocal microscopy (IVCM)

Other

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

Primary outcomes

  1. Peripheral Corneal Immune cell Status by IVCM

    Time frame: 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

    Time frame: 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 outcomes

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

    Time frame: Visit 1

  2. Clinical Parameter: Schirmer's II test

    Time frame: Visit 1

  3. Clinical Parameter: Conjunctival staining with lissamine green

    Time frame: Visit 1

  4. Clinical Parameter: Corneal staining with fluorescein

    Time frame: Visit 1

  5. Clinical Parameter: Tear Break Up Time (TBUT)

    Time frame: Visit 1

  6. Clinical Parameter: Conjunctival redness

    Time frame: Visit 1

Sponsors and collaborators

Lead sponsor

Tufts Medical Center

Other

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jan 23, 2014
Registry last updated
Oct 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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