Topical Fibrinogen-Depleted Human Platelet Lysate in Patients With Dry Eye Secondary to Graft vs. Host Disease

Exclusion Criteria

• •1. Any abnormal lid anatomy or blinking function in either eye;
• •2. Any history of other ocular disease requiring topical ocular treatment other than artificial tears and/or Restasis® (cyclosporine ophthalmic emulsion; Allergan Irvine, CA) or Xiidra® (lifitegrast, Shire, Lexington, MA). Patients currently using Restasis® or Xiidra® for conditions other than DED (e.g., allergies);
• •3. Previous intraocular or ocular laser surgery within the past 3 months or any refractive surgery procedure within the past 6 months of the screening visit in either eye;
• •4. Any relevant ocular anomaly interfering with the ocular surface, including active ocular herpes simplex infection, recurrent corneal erosion, symptomatic epithelial basement membrane dystrophy, mucus fishing syndrome, giant papillary conjunctivitis, post-radiation keratitis, Stevens-Johnson syndrome, corneal ulcer, abnormalities of the nasolachrymal drainage system, chemical injury, destruction of the conjunctival goblet cells or scaring, diagnosed significant anterior blepharitis and/or progressive pterygium, or any other additional condition(s) associated with or causing dry eye;
• •5. Presence or history of any ocular disorder or condition, including ocular surgery (including palpebral and cataract surgery, trauma), infection (viral, bacterial, fungal), disease or inflammation not associated with dry eye unless disorder or disease is:
• •1. Stable for at least 3 months before the Screening Visit; and
• •2. As determined by the Investigator not likely to impact or possibly interfere with the interpretation of study results.
• •6. History of ocular allergy (including seasonal conjunctivitis) or chronic conjunctivitis other than dry eye;
• •7. Known hypersensitivity to one of the components of the study or procedural medications (e.g., fluorescein, lissamine green, Refresh Plus®);
• •8. Inability to refrain from contact lens wear during the study, including the 2 week Run-in period;
• •9. Anticipated temporary or permanent need for punctal plugs during the study, except if punctal plugs have been in place for at least 2 weeks prior to Screening, in which case the plugs are allowed to remain in place during the study; if plugs should fall out during the course of the study, the instance will be recorded and the plug(s) can be replaced;
• •10. Ocular or clinically significant systemic disease (e.g., diabetes with glycemia out of range, thyroid malfunction, uncontrolled autoimmune disease) or condition(s) not stabilized within 1 month (30 days) before Screening or a condition judged by the Investigator to be incompatible or interferes with the study results;
• •11. Inability or unwillingness to discontinue use of autologous or platelet rich plasma eye drops during the 2 week washout period and the duration of the study;
• •12. Anticipated change in the use or dose of Restasis®, Xiidra®, or artificial tears within 14 days before Screening or during the study. If currently taking Restasis®, Xiidra®, or artificial tears, treatment(s) for DED can continue throughout the study without a change in dose. If currently using Restasis® or Xiidra® for conditions other than DED, then patient will be excluded from study. If not currently taking Restasis®, Xiidra® or artificial tears, these drugs cannot begin during the study;
• •13. Anticipated change in the patient's use of or dosage of systemic medications that could affect tear function (e.g., antihistamines, tricyclic antidepressants, anxiolytics, antimuscarinics, beta-blocking agents, phenothiazines, tacrolimus, sirolimus, etc.) during the study. If currently taking any of these drugs, treatment(s) can continue throughout the study without a change in dose;
• •14. Pregnancy or breast feeding at the time of study entry;
• •15. History of clinically significant drug or food allergy;
• •16. Positive HIV, hepatitis B or C viral test at screening;
• •17. History, as judged by the Investigator, of drug or alcohol abuse (i.e., alcohol consumption \>2 drinks/day over the last 3 months prior to screening); drug abuse is any use of illegal drugs or prescription-drug over usage or addiction;
• •18. Taken any investigational medication and/or participated in any clinical studies within 30 days of screening;
• •19. Any patient who, in the judgment of the Investigator, may not be able to cooperate fully with the study staff, may have difficulty following some study requirements, or is otherwise not qualified for the study;
• •20. Any patient who is directly involved in the conduct of the protocol.