Seasonal allergic conjunctivitis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients diagnosed as seasonal allergic conjunctivitis due to cedar pollen in the both eyes 2. Allergy test-positive patients (type I allergy) in the one of the following tests (test result obtained within the past 5 years can be used) : (1) Serum antigen-specific IgE antibody assey (2) Skin test such as intradermal test and scratch test (3) Rapid antigen test with ImmunoCAP Rapid 3. Patients aged 12 years or older (Parental Consent is required for patients under 20 years old) 4. Sex: male and female
Exclusion criteria
Exclusion criteria: 1. Patients using contact lenses with difficulty in use of ophthalmic solution 2. Patients given immunotherapy (hyposensitization therapy, modulated therapy) 3. Patients with surgical history in the internal eye (including laser therapy) within 3 months prior to enrollment 4. Patients with allergy to drugs (including fluorescein) to be used during the research 5. Patients taking medicines (including steroid and immunosuppressive drugs) which affects the efficacy of study drug within 14 days prior to enrollment (patients can use drugs except for steroid and immunosuppressive drugs unless amount of drug is changed during the research) 6. Pregnant women, women of child-bearing potential or lactating women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Change in scores of subjective symptoms (itch sensation, foreign body sensation, congestion, lacrimation, eye mucus) 2. Change in scores of objective symptoms (JACQLQ) 3. Change in patient-reported outcomes (JACQLQ) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Frequency in use of steroid eyedrops 2. Patient diary of allergic symptoms | — |
Countries
Japan
Contacts
Quintiles Transnational Japan K.K. Medical & regulatory affairs division