Table 3.

Study Procedures Order of Testing for the DRy Eye Assessment and Management (DREAM©) Study.

Primary study	Visit (Month)
Procedure	−2wks SV	00	03	06	09	12
Obtain informed consent	X					Y
OSDI & BODI questionnaires	X	X	X	X		X
Health economics questionnaires (SF-36, WPAI, Healthcare Use)		X		X		X
Medical history and events	X	X	X	X		X
Concomitant medication query		X	X	X		X
Adverse event query		X	X	X		X
MMP-9 testing	X		X
Tear osmolarity		Xb		Xb		Xb
Keratograph: Break-up time, tear meniscus height, redness and meibomian gland evaluation		Xb		Xb		Xb
Manifest refraction		X
Best corrected VA (if change in VA ≥ 10 letters, do refraction)		X	X	X		X
Contrast sensitivity		X		X		X
Tear collection for cytokines		Xb		Xb		Xb
Slit lamp evaluation (SLE)	X	X	X	X		X
Tear break-up time (TBUT)e	X	X	X	X		X
Corneal fluorescein staininge	X	X	X	X		X
Meibomian gland examinatione	X	X	X	X		X
Lissamine green staininge	X	X	X	X		X
IOP	X	X	X	X		X
Schirmer’s tear test (with anesthetic)	X	X	X	X		X
Urine pregnancy test	Xa					Ya
Eligibility determination	X	X				X
Impression cytology		X		X		X
Blood collection (Mon-Thurs) for fatty acid determination		X		X		X
Blood collection (Mon-Thurs) for antibody determination		X				X
Collection of unused study supplements		X	X	X		X
Randomization		X				Y
Dispense run-in supplements	X
Reminder calls (2 weeks before each visit)		X	X	X		Xc
“Check-In” telephone call					X	Xd
Letter to encourage compliance (sent 1 month after each visit)		X	X	X		Y

SV: Denotes screening visit; 00: Denotes eligibility confirmation visit. Y: Only patients in the Extension Study.

^aOnly women of childbearing potential.

^bOnly at centers with required equipment.

^cCall should include information about the Extension Study.

^dCall for final adverse event assessment if not in Extension Study.

^eDo all 4 procedures OD, then restart for OS.