The main objective of this study is to establish whether patients with Dry Eye Disease are able to safely tolerate receiving Intravenous Immunoglobulin (IVIG) eye drops two times a day for eight weeks (primary 'safety and tolerability' objective). The exploratory objective is to investigate the preliminary efficacy of the use of IVIG eye drops in treating Dry Eye Disease (exploratory efficacy objective) to estimate the effectiveness of the trial intervention and collecting data to inform the design of a future definitive trial.
This will be a Randomized controlled trial, in which a total of 28 subjects will be enrolled at 1 clinical site. Subjects will be randomly assigned to one of two groups (#1, #2), with 14 subjects per group. One group will be given placebo (Normal saline eye drops) and the other group will be given eye drops containing the study drug (IVIG).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Sign and date the informed consent form approved by the Institutional Review Board (IRB)
✓. ≥ 18 years of age
✓. Demonstrate at least any 2 of the following signs in the same eye or a sign and symptom.
✓. Conjunctival staining present ≥ 1 (out of possible score of 6 per eye)
✓. Corneal staining present ≥ 2 (out of a possible score of 15 per eye)
✓. Tear film break up time (TFBUT) ≤ 7 seconds
✓. Schirmer's test ≥ 0 to ≤ 9 mm/5min
✓. Superior Limbic Keratoconjunctivitis (SLK) pattern staining ≥ 1
Exclusion criteria
✕. Allergic to IVIG or any similar products, or excipients of IVIG eye drops 4 mg/ml.
✕. Use of contact lenses within the last 2-weeks prior to the baseline Visit.
What they're measuring
1
Tolerability: The Primary Tolerability Endpoint is the Test Substance Tolerance (Visual Analog Scale) at 8 Weeks (56 Days)