Ocular Surface Immune Response in Dry Eye Disease

Dry Eye Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02042820
• Other study ID #: 13-149H
• Status: Completed
• Phase: N/A
• First received: January 17, 2014
• Last updated: October 16, 2017
• Start date: January 2014
• Est. completion date: July 2015

Study information

• Verified date: October 2017
• Source: Tufts Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dry Eye Disease
• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca

Intervention

Other:
• In vivo confocal microscopy (IVCM)
IVCM is a sensitive tool for detecting dry eye-associated subclinical inflammation.

Locations

Country	Name	City	State
United States	Massachusetts Eye and Ear Infirmary	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Tufts Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Clinical Parameter: Ocular Surface Disease Index (OSDI)		Visit 1
Secondary	Clinical Parameter: Schirmer's II test		Visit 1
Secondary	Clinical Parameter: Conjunctival staining with lissamine green		Visit 1
Secondary	Clinical Parameter: Corneal staining with fluorescein		Visit 1
Secondary	Clinical Parameter: Tear Break Up Time (TBUT)		Visit 1
Secondary	Clinical Parameter: Conjunctival redness		Visit 1