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Presentation typeOB - oral
TitleFRO: The Slug Mucosal Irritation (SMI) assay: A tool to predict ocular stinging, itching and burning sensations
PurposeEyes are very sensitive to stinging, itching and burning (SIB) sensations. A screening method for ocular discomfort would be very helpful in the development and refinement of ocular formulations. The Slug Mucosal Irritation (SMI) test was developed as an alternative for the Draize test (eye irritation test in rabbits). The aim of this study was to investigate whether the SMI-test could also demonstrate a relation between an increased mucus production (MP – expressed as % of initial body weight) in slugs and an elevated incidence of SIB sensations in human eyes by using shampoos as test substance.
MethodsThe stinging potency of an artificial tear (ArtTear) and 5 shampoos (A-E) was evaluated with the SMI-test by placing 3 slugs per treatment 3 times on 100µl of the test item. After each 15-min contact period (CP), MP was measured. Evaluation of the results is based upon the total MP during the 3 repeated CPs. Additionally, a human eye irritation test (HEIT) was set up: 24 participants were dripped 10µl of a shampoo dilution in water or an artificial tear in one eye, while in the other eye 10µl of water was instilled (control). Evaluation of the test items was performed both by participants and an ophthalmologist at several time points (30 sec up to 30 min).
ResultsAnalyses reveal that (1) a significant positive association existed between immediate stinging reaction reported by the participants and the mean total mucus produced by the slugs (MTMP) (Spearman’s Rank correlation = 0.986, p<0.001); (2) ArtTear was best tolerated in both tests; (3) moreover, all shampoos induced higher reactions than ArtTear and water; (4) Shampoo B was the best tolerated shampoo in both tests, while C, D and E resulted in more pronounced reactions; (4) Shampoo A induced the highest MTMP and received higher scores for immediate discomfort; (6) lacrimation might not be a valuable parameter to evaluate the general tolerance of a product.
ConclusionThese results indicate that the SIB protocol of the SMI-test is a good tool to predict clinical ocular discomfort with reference to non- and mildly irritating formulations in humans.
Author 1
Last nameLENOIR
InitialsJ
DepartmentLab of Pharmaceutical Technology, Ghent University
CityGent
Author 2
Last nameCLAERHOUT
InitialsI
DepartmentDept. of Ophthalmology, Ghent University Hospital
CityGent
Author 3
Last nameKESTELYN
InitialsP
DepartmentDept. of Ophthalmology, Ghent University Hospital
CityGent
Author 4
Last nameREMON
InitialsJP
DepartmentLab of Pharmaceutical Technology, Ghent University
CityGent
Author 5
Last nameADRIAENS
InitialsE
DepartmentLab of Pharmaceutical Technology, Ghent University
CityGent
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