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
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      IVCM is a non-invasive imaging technique that images the cornea at a cellular level with 800x
      magnification, using a scanning laser. The laser is used to map the cornea, and will not
      damage or harm the subject's eye. Studies have shown that IVCM can be used to study cells and
      nerves within the cornea, providing a better understanding of how the cornea reacts to
      irritants. IVCM has recently been used by the investigator to assess the extent of eye
      inflammation in cases of dry eye patients.

      Current steroid therapy in dry eye disease (DED) is comprised of a 2 week duration of pulse
      therapy, administered twice daily (to avoid adverse effects associated with long-term steroid
      use). This time frame is often too short to meaningfully resolve the inflammation associated
      with DED. DED often occurs when there is a decrease in the eye's tear production or if there
      is an increase in the evaporation of the tear film (a thin layer of tears that keep the eye
      moist). Eye irritation and inflammation (swelling) is often associated with DED because the
      surface of the eye is unable to maintain a normal level of moisture.
    

Intervention name(s): Lotemax; Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears); In Vivo Confocal Microscopy (IVCM)
Intervention type(s): Drug; Drug; Diagnostic Test
Intervention description(s): 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.
Other intervention name(s): Lotemax (loteprednol etabonate) 0.5%; Soothe Tired Eyes Lubricant Eye Drop (Bausch & Lomb Inc.)
Intervention MeSH terms: Loteprednol Etabonate; Ophthalmic Solutions; Lubricant Eye Drops
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Dry Eye