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Dry Eye Disease | The Utility of IVCM to Assess Cellular Response and Efficacy of Long-term Topical Steroid Treatment in Patients With DED

Dry Eye Disease research study

What is the primary objective of this study?

This research study is looking to see if in vivo confocal microscopy (IVCM) imaging can be used to confirm clinical findings (which are noted by the doctor during an eye exam) and measure the immune response to the inflammation in the subject's cornea (the front part of the eyeball). Additionally, this study is trying to determine the effectiveness of two eye-drops, Lotemax and artificial tears, in treating the inflammation associated with DED by measuring changes in immune cells with IVCM imaging. The subject will be treated with either Lotemax (loteprednol) or artificial tears (a lubricating eye drop with no medication). Lotemax is an FDA-approved steroid eye-drop that is often used to treat inflammation associated with DED. Artificial tears are approved by the FDA for treatment of dryness associated with DED. Thus, this study is designed to determine the effects of the administration of a topical steroid, Lotemax, over a treatment period of 6 weeks, using novel methods of detecting efficacy. In order to achieve the aforementioned goal, subjects will be prospectively randomized to one of two treatment arms - Lotemax or artificial tear. Both groups will follow the same study schedule.

Who is eligible to participate?

Inclusion Criteria: - Age 18-89 years. - Willing and able to provide written informed consent. - Willing and able to comply with study assessments for the full duration of the study. - In good stable overall health. - Corneal dendritiform cell count by confocal microscopy of >=75/mm2 (13 immune cells per image) - Diagnosis of dry eye disease based on the followings: - Symptoms of dry eye disease such as foreign body sensation, burning, stinging, light sensitivity for at least 6 months. - Two or more of the following objective signs: - Schirmer test with anesthesia <10 mm at 5 minutes [mean Schirmer between eyes. - Tear break-up time (TBUT) of <10 seconds. - Corneal fluorescein staining of 4 (NEI grading scheme, 0-15) in at least one eye - Lissamine green staining of the nasal and temporal conjunctiva (NEI grading scheme, 0-18) in at least one eye Exclusion Criteria: - Central corneal subbasal dendritic cell count by in vivo confocal microscopy of <75/mm2 in both eyes - Active ocular allergies - Active allergies to steroids, aminoglycosides, or benzalkonium chloride (BAK) - History of contact lens wear within 3 months before enrollment. - Intraocular surgery or ocular laser surgery within 3 months before enrollment. - History of ocular infection within 3 months before enrollment. - History of topical (for ophthalmic use) or systemic steroid treatment (Loteprednol (other than Lotemax suspension used in our study), Difluprednate, Fluorometholone, Prednisolone, Dexamethasone, Triamcinolone, Rimexolone, Medrysone) within 1 month before enrollment. In case of topical ophthalmic steroid use, a wash-out period of 1 month is required. - History of increased intraocular pressure after using topical steroids (steroid responsive) - Change in systemic immunosuppression medication in the past 3 months. - History of any change in the frequency of topical cyclosporine or oral tetracycline compounds (tetracycline, doxycycline, and minocycline) within 1 month before enrollment. - Any condition (including language barrier) that precludes subject's ability to comply with study requirements including completion of study.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Dry Eye Disease

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:LotemaxLotemax (loteprednol etabonate) 0.5% will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks.

Drug:Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears)Soothe Tired Eyes Lubricant Eye Drop will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks.

Diagnostic Test:In Vivo Confocal Microscopy (IVCM)In vivo confocal microscopy (IVCM) is a new imaging method, which allows visualization of the corneal structures at the cellular level. With a magnification of 800 times, it makes it possible to detect and quantify changes in the epithelial layers and sub-basal nerve plexus.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Lotemax

Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears)

Study Status

Completed

Start Date: February 2014

Completed Date: January 28, 2018

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: In Vivo Confocal Microscopy (IVCM) for determination of density of superficial corneal epithelial cells

Secondary Outcome: Ocular Signs: Corneal epitheliopathy

Study sponsors, principal investigator, and references

Principal Investigator: Pedram Hamrah, MD

Lead Sponsor: Tufts Medical Center

Collaborator:

More information:https://clinicaltrials.gov/show/NCT02120079

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