IVIG-eye Drops Treatment for Dry Eye Disease

Inclusion Criteria

• •1. Sign and date the informed consent form approved by the Institutional Review Board (IRB)
• •2. ≥ 18 years of age
• •3. Demonstrate at least any 2 of the following signs in the same eye or a sign and symptom.
• •1. Conjunctival staining present ≥ 1 (out of possible score of 6 per eye)
• •2. Corneal staining present ≥ 2 (out of a possible score of 15 per eye)
• •3. Tear film break up time (TFBUT) ≤ 7 seconds
• •4. Schirmer's test ≥ 0 to ≤ 9 mm/5min
• •5. Superior Limbic Keratoconjunctivitis (SLK) pattern staining ≥ 1
• •6. Meiboscale grade ≥ 2
• •7. Validated Bulbar Redness ≥ 40
• •8. Demonstrate symptoms of dry eye disease Ocular Surface Disease Index (OSDI) score of at least ≥ 13.
• •9. Demonstrate Symptom Intensity Assessment of ≥ 3.
• •4. Patient reported dry eye-related ocular symptoms for at least 6 months before the Screening Visit and use or desire to use artificial tears on average 2 times per day in the 2 weeks preceding the screening visit
• •5. Intraocular pressure (IOP) ≥ 5 mmHg and ≤ 22 mmHg in each eye
• •6. Women of child-bearing potential must agree to use a reliable method of contraception during study participation and must demonstrate a negative pregnancy test at the Screening Visit
• •7. Be willing/able to return for all study visits and to follow instructions from the study investigator and his/her staff
• •8. Ocular Surface Wash Anti-Citrullinated Protein Antibody (ACPA) value of \> 4.4 units in either eye at any time in the past.