Clinical trial NCT02042820: Ocular Surface Immune Response in Dry Eye Disease
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dry Eye Disease
Keywords: Dry Eye
Lead sponsor: Tufts Medical Center
Sponsor class: OTHER
First posted: 2014-01-23
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with and without Dry Eye Disease

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.


Eligibility 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

Primary outcomes:
measure: Peripheral Corneal Immune cell Status by IVCM
timeFrame: Visit 1
measure: Bulbar conjunctival immune cell Status by IVCM
timeFrame: Visit 1
Secondary outcomes:
measure: Clinical Parameter: Ocular Surface Disease Index (OSDI)
timeFrame: Visit 1
measure: Clinical Parameter: Schirmer's II test
timeFrame: Visit 1
measure: Clinical Parameter: Conjunctival staining with lissamine green
timeFrame: Visit 1
measure: Clinical Parameter: Corneal staining with fluorescein
timeFrame: Visit 1
measure: Clinical Parameter: Tear Break Up Time (TBUT)
timeFrame: Visit 1
measure: Clinical Parameter: Conjunctival redness
timeFrame: Visit 1
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts Eye and Ear Infirmary
state: Massachusetts
Study officials:
affiliation: MEEI
name: Pedram Hamrah, MD
role: PRINCIPAL_INVESTIGATOR
References: