Patent ID: 8871995

Claim:
A method for screening an agent being useful for the treatment of dry eye and/or corneal and conjunctival lesion of dry eye severity level 3 or more according to the table below: Dry eye severity grading scheme Dry Eye Severity Level 1 2 Discomfort, severity Mild and/or episodic Moderate episodic or & frequency occurs under environ chronic stress or no stress stress Visual symptoms None or episodic mild Annoying and/or fatigue activity limiting episodic Conjunctival None to mild None to mild injection Conjunctival None to mild Variable staining Corneal staining None to mild Variable (severity/location) Corneal/tear signs None to mild Mild debris, ↓ meniscus Lid/meibomian glands MGD variably present MGD variably present TFBUT (sec) Variable ≦10 Schirmer score Variable ≦10 (mm/5 min) Dry Eye Severity Level 3 # 4* Discomfort, severity Severe frequent or Severe and/or & frequency constant without disabling and stress constant Visual symptoms Annoying, chronic Constant and/or and/or constant possibly disabling limiting activity Conjunctival +/− +/++ injection Conjunctival Moderate to Marked staining marked Corneal staining Marked central Severe punctate (severity/location) erosions Corneal/tear signs Filamentary Filamentary keratitis, mucus keratitis, mucus clumping, ↑ tear clumping, ↑ tear debris debris, ulceration Lid/meibomian glands Frequent Trichiasis, keratinization, symolepharon TFBUT (sec) ≦5 Immediate Schirmer score ≦5 ≦2 (mm/5 min) # Must show at least one of signs and symptoms. *Must have signs AND symptoms. TFBUT: fluorescein tear break-up time. MGD: meibomian gland disease. wherein said method comprises preparing a model rabbit of corneal and conjunctival lesion having corneal and conjunctival epithelial abrasion by instilling n-heptanol solution to an eye of a rabbit such that the n-heptanol solution spreads over cornea and bulbar conjunctiva, and forcing the rabbit to blink; and administering a test agent to the eye of the model rabbit and determining an effect of restoring corneal tissue of the test agent by (i) staining the eye with a dye to show corneal lesion and (ii) observing a change in amount of staining in the eye over time, wherein an agent that is useful for said treatment reduces the amount of staining in the eye over time, wherein the preparing step further comprises forcing the rabbit to close the eye for about 1 to about 3 minutes.