The Utility of IVCM to Assess Cellular Response and Efficacy of Long-term Topical Steroid Treatment in Patients With DED
Condition: Dry Eye Disease
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Eye Diseases
Intervention: Lotemax; Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears); In Vivo Confocal Microscopy (IVCM)
Intervention description: Lotemax (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.; 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.; 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.
Intervention MeSH terms: Loteprednol Etabonate; Ophthalmic Solutions; Lubricant Eye Drops
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 38.0
Sex: All
Minimum age: 18 Years
Maximum age: 89 Years
Healthy volunteers: No
Keywords: Dry Eye

Summary:

      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.
    

Eligibility criteria:

        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.