Dry Eye
Conditions
Interventions
investigational material(s)
Generic name etc : Diquas ophthalmic solution 3%
INN of investigational material : diquafosol
Therapeutic category code : 131 Agents for ophthalmic use
Dosage and Administr
Sponsors
SANTEN PHARMACEUTICAL CO., LTD.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) 20 years of age or older 2) Male or Female 3) Inpatients or outpatients Outpatients 4) The subject who is received a definitive diagnosis of dry eye based on the 2006 Dry eye 5) diagnostic criteria in both eyes 6) The subject who has the results (average of the longest part and the shortest part) of Shirmer test without anesthesia (5 minutes) less than 10 mm in both eyes
Exclusion criteria
Exclusion criteria: 1) Has the ocular condition which needs treatment expect dry eye 2) Has the allergic conjunctivitis which has fear of worsen during the study period 3) Has received intraocular operation (including laser treatment) within 90 days before start of screening period 4) Has received treatment in order to close the punctal (ex. punctal plug or a punctal closing surgery) within 30 days before start of screening period 5) Has necessary to wear contact lenses on the study drug dose day
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| At second time, the amount change of tear secretion (by Schirmer test) from baseline The amount change of tear secretion is compared between study drug groups by ANOVA with study drug, the target eye and subject as factors. | — |
Outcome results
None listed