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Clinical research of Alesion ophthalmic solution in patients with seasonal allergic conjunctivitis

Clinical research of Alesion ophthalmic solution in patients with seasonal allergic conjunctivitis - Clinical research of Alesion ophthalmic solution in patients with seasonal allergic conjunctivitis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000012715
Enrollment
260
Registered
2014-01-01
Start date
2014-01-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Seasonal allergic conjunctivitis

Interventions

Alesion ophthalmic solution is administered prior to pollen dispersal Alesion ophthalmic solution is administered posterior to pollen dispersal

Sponsors

Medical company "Keisyo Kai"
Lead Sponsor

Eligibility

Sex/Gender
All

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

MeasureTime 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

MeasureTime frame
1. Frequency in use of steroid eyedrops 2. Patient diary of allergic symptoms

Countries

Japan

Contacts

Public ContactStudy support center

Quintiles Transnational Japan K.K. Medical & regulatory affairs division

Kafun_Chiryo@quintiles.com06-4807-9800

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026