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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02042820
Other study ID # 13-149H
Secondary ID
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
Health authority
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

Study Design


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
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