TITLE: A Double-Masked, Randomized, Multi-Center Phase 2 Study to Evaluate the Efficacy and Safety of Lacripep™ in Subjects With Dry Eye Associated With Primary Sjögren's Syndrome
ELIGIBILITY: You must have been diagnosed with primary Sjogrens Syndrome. See Inclusion Criteria and Exclusion Criteria for more information.
LOCATIONS: 28 locations in the US.
DESCRIPTION: TearSolutions is currently studying Lacripep(TM) in a Phase 2 clinical trial as a replacement therapy for the treatment of dry eye in patients diagnosed with primary Sjogren's Syndrome. Lacripep(TM) contains a 19 amino acid peptide found in normal tear, which is deficient in all forms of dry eye, but more severely deficient in primary Sjogren's sufferers. Experimental studies prior to the current clinical trial demonstrated that Lacripep(TM) restored the health of the ocular surface to normal (homeostasis) and improved basal tearing. The restoration of the ocular surface health is measured in the Phase 2 study as a decrease in fluorescein corneal staining and basal tearing is monitored by the Schirmer Tear Test. If successful in this intiial Phase 2 study, TearSolutions could file for approval by the FDA in 2020. More information including a description of the clinical trial and 30 clinical sites where subjects can enroll can be found at www.tearsolutions.com. If you are within 150 miles of one of the clinical sites, a Google search of Sjogren's Syndrome or severe dry eye on your smartphone can connect you to that site.
TITLE: Effectiveness of Intense Pulsed Light for Improving Dry Eye Syndrome
ELIGIBILITY: TBUT <=7; MGS <=12; OSDI >=23. See Inclusion Criteria and Exclusion Criteria for more information.
LOCATIONS: Nashville TN and Austin TX.