1. Dry Eye Assessment and Management Penny Asbell, MD, MBA Brendan Barry, BA Seth Epstein, MD Yi Wei, PhD

2. May provide key information to differentiate DED subjects Expand our knowledge of the mechanism of action leading to DED Lead to new targets for treatment of DED

3.  Personnel : sites are responsible to train IATA- certified personnel before shipping ;  Frequency : shipping at least twice /year,  Service type: overnight delivery by FedEx with dry ice;  Shipper kit : delivered to sites, two weeks before expected shipping date set by Biomarker Lab  Dry ice: Ordered by sites, one week before expected shipping date from local dealer.

4. Only personnel with IATA certification can ship Must have submitted DREAM certification forms

5. 1. Copies of each sample’s Tear Sample Registration Form 2. Shipping Log 3. Shipper Declaration Form

8. INFECON-5000 Shipper kit Standard-grade packing tape Scotch tape Parafilm Dry Ice, 5 lb/bag

9. 1. A liquid-tight 0.5L polyethylene pressure vessel, withstand 95 kPa pressure; 2. 5.6 lb of dry ice, last for 60 hours; 3. All required labels and markings included; 4. Compact size and shipping weight; 5. INF-9875 Return Label; 6. Packing instructions printed on shipper box flap; 7. Inside dimensions: 7.5 x 4.25 x 8.5 in.(0.5L vessel); 8. Outside dimensions: 11 x 8 x 12.25 in. 9. Additional parts are available upon request. Complies with U.N. regulations, ICAO/IATA Packing Instruction 602 and 904 and applicable DOT regulations

10. 7.5 Yi Wei/Seth Epstein/Ines Lashley Department of Ophthalmology, Box 1183 Annenberg Building, Rm 22-11 Icahn School of Medicine at Mount Sinai 1 Gustave L Levy Place, New York, NY 10029 Tel: (212) -824-7644(Off); (212) 241-6795(Lab); Fax: (212) 241-4550 Email: yi.wei@mssm.edu

11. Yi Wei/Seth Epstein/Ines Lashley Department of Ophthalmology, Box 1183 Annenberg Building, Rm 22-11 Icahn School of Medicine at Mount Sinai 1 Gustave L Levy Place, New York, NY 10029 Tel: (212) -824-7644(Off); (212) 241-6795(Lab); Fax: (212) 241-4550 Email: yi.wei@mssm.edu Attn: Meng C. Lin, OD, PhD University of California, Berkeley School of Optometry Clinical Research Center 381 Minor Hall Berkeley, CA 94720-2020 Phone: (510) 643-9252; FAX: (510) 643-4202

12. Sites should maintain their own Temperature Freezer Log Temperature should be checked daily Use gloves when removing tear sample storage box

13. Sites are responsible for ordering from local dealer Must order one week before expected shipping date Avoid direct skin contact when handling dry ice – always wear gloves Place vessel on dry ice during shipment preparation

14. Immediately place tubes on dry ice when removed from Ultra-cold freezer or liquid nitrogen. ― Samples will melt Examine the collecting tubes to ensure they are: ― Tightly closed and sealed with Parafilm (re-seal if needed) ― Labels are legible and match Tear Registration Form

15. Insert 1 sample tube into each cell of the bubble bag (1/cell) ― 6/bubble bag; 30/shipper kit If placing more than 1 tube per cell, ensure there is no contact between tubes (use cotton, tape, etc) Seal and wrap the bubble bag and insert into vessel

16.  Properly seat “O” ring into the lid  Slide pieces of dry ice in the bottom chamber  Place the properly closed vessel back into the Shipper kit, making certain it is seated in the die- cut foam insert

17.  Fill Shipper with 5 lb of dry ice around vessel  Cover the chamber with blue foam  Insert all 3 forms in the space between the two boxes  Seal the box with provided packing tape

18.  Secure to the box: ― shipping labels ― hazardous materials labels  Call FedExfor pick up or send to a nearby FedEx store for overnight delivery

19. X FedEx Label with “Dry Ice” Checked

20.  INFECON 5000 Shipper kit will be sent two weeks before your expected shipping date  You will be expected to order dry ice from a local provider one week prior to expected shipping date  Shipping date should always be arranged on Monday or Tuesday; avoid any holidays or long weekends.  Must e-mail Biomarker Lab with each shipment to alert them the # of samples and the date of shipment

21. Yi.wei@mssm.edu (212)-241-6795