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1. 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 schemeDry Eye Severity Level12Discomfort, severity Mild and/or episodicModerate episodic or& frequencyoccurs under environchronic stress or nostressstressVisual symptomsNone or episodic mildAnnoying and/orfatigueactivity limitingepisodicConjunctivalNone to mildNone to mildinjectionConjunctival None to mildVariablestainingCorneal stainingNone to mildVariable(severity/location)Corneal/tear signsNone to mildMild debris, ↓meniscusLid/meibomian glandsMGD variably presentMGD variably presentTFBUT (sec)Variable≦10Schirmer scoreVariable≦10(mm/5 min)Dry Eye Severity Level3#4*Discomfort, severity Severe frequent or Severe and/or & frequencyconstant withoutdisabling and stressconstantVisual symptomsAnnoying, chronicConstant and/or and/or constantpossibly disablinglimiting activityConjunctival+/−+/++injectionConjunctival Moderate toMarkedstainingmarkedCorneal stainingMarked centralSevere punctate (severity/location)erosionsCorneal/tear signsFilamentaryFilamentarykeratitis, mucuskeratitis, mucus clumping, ↑ tearclumping, ↑ tear debrisdebris, ulcerationLid/meibomian glandsFrequentTrichiasis, keratinization,symolepharonTFBUT (sec)≦5ImmediateSchirmer 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. |
