Ocular Surface Immune Response in Dry Eye Disease
Completed
Conditions studied: Dry Eye Disease
In brief
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.
Key facts
- Study ID
- NCT02042820
- Run by
- Tufts Medical Center
- People needed
- 67
- Starts
- 2014-01-01
- Expected to finish
- 2015-07-01
- Last updated by the study team
- 2017-10-18
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Massachusetts Eye and Ear Infirmary — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.