Ocular Surface Immune Response in Dry Eye Disease

Completed

• Conditions: Dry Eye Disease
• Interventions: Other: In vivo confocal microscopy (IVCM)

• Registration Number: NCT02042820
• Lead Sponsor: Tufts Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-01-17
• Study First Submitted QC: 2014-01-20
• Study First Posted: 2014-01-23
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-16
• Last Update Posted: 2017-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Dry Eye Disease	In vivo confocal microscopy (IVCM)	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
Control	In vivo confocal microscopy (IVCM)	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

Primary Outcome Measures

Name	Time	Method
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
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

Secondary Outcome Measures

Name	Time	Method
Clinical Parameter: Ocular Surface Disease Index (OSDI)	Visit 1
Clinical Parameter: Conjunctival staining with lissamine green	Visit 1
Clinical Parameter: Tear Break Up Time (TBUT)	Visit 1
Clinical Parameter: Schirmer's II test	Visit 1
Clinical Parameter: Corneal staining with fluorescein	Visit 1
Clinical Parameter: Conjunctival redness	Visit 1

Trial Locations

Locations (1)

Massachusetts Eye and Ear Infirmary; 🇺🇸 Boston, Massachusetts, United States