Subjects with moderate-to-severe Dry Eye by symptoms will be screened including history,
ophthalmic examination to include the status of their ocular structure and function and
evaluation of tear production. Blood will be blood drawn for complete blood count and
chemistry panel. They will also have a urinalysis and pregnancy test in women of
child-bearing potential.
Subjects will have a two week "run-in" period in which they use artificial tears. If their
Dry Eye signs and symptoms do not improve significantly, they will be enrolled and will
receive study drug.
Safety evaluation includes assessment of the structure and function of the eyes including
retina examination and corrected visual acuity.
Subjects who meet the inclusion and exclusion criteria will be randomly assigned to one of
two treatment arms, ST266 or "artificial tears" eye drops. The randomization scheme is 1:1
ST266:artificial tears. Subjects will self-administer their eye drops four times each day.
Subjects will be seen in the office of the ophthalmologist/optometrist at baseline (week
zero), one week, three weeks, six weeks and ten weeks. Eye examination will be done at each
visit. The baseline eye tests and lab work will be repeated after the treatment phase of the
study at the end of week six. Following 6 weeks of treatment, the subjects will be followed
for 4 additional weeks.