Seasonal or perennial allergic conjunctivitis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) Written informed consent was obtained after adequate explanation on participating the study. For minors (age < 20 years) participating in the study, informed consent was obtained from a legally authorized representative, and minor assent or informed consent was obtained from minors participating in the study 2) Japanese male or female outpatient, 10 years of age or older 3) Females of childbearing potential must have a negative blood pregnancy test at screening and must not be breastfeeding. 4) Diagnosis of seasonal or perennial allergic conjunctivitis
Exclusion criteria
Exclusion criteria: 1) History of allergic hypersensitivity or known hypersensitivity to the study drug or its ingredients 2) History of vernal conjunctivitis or atopic conjunctivitis 3) History of retinal detachment or diabetic retinopathy or presence of any retinal disease that may progress 4) Presence of active ocular disease (bacterial, fungal or viral) or preauricular lymphadenopathy or a positive history of an ocular herpetic infection 5) Under hyposensitization therapy or anticipated use 6) Previously received hyposensitization therapy with negative result in the allergic test at screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes from the baseline (Visit 2) in ocular itching frequency score at Visit 5 (the last visit) or at the discontinuation of treatment | — |
Countries
Japan
Contacts
Senju Pharmaceutical co.,ltd. Clinical Development