Unique ID issued by UMIN | UMIN000012715 |
---|---|
Receipt number | R000014846 |
Scientific Title | Clinical research of Alesion ophthalmic solution in patients with seasonal allergic conjunctivitis |
Date of disclosure of the study information | 2014/01/01 |
Last modified on | 2015/09/08 12:32:17 |
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
Clinical research of Alesion ophthalmic solution in patients with seasonal allergic conjunctivitis
Japan |
Seasonal allergic conjunctivitis
Ophthalmology |
Others
NO
To compare clinical efficacy of Alesion ophthalmic solution between patients with seasonal allergic conjunctivitis due to cedar pollen, who started treatment before pollen dispersal (prior treatment group) and who started treatment after pollen dispersal (standard treatment group)
Efficacy
Confirmatory
Pragmatic
Not applicable
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)
1. Frequency in use of steroid eyedrops
2. Patient diary of allergic symptoms
Interventional
Parallel
Non-randomized
Open -no one is blinded
Active
2
Treatment
Medicine |
Alesion ophthalmic solution is administered prior to pollen dispersal
Alesion ophthalmic solution is administered posterior to pollen dispersal
12 | years-old | <= |
Not applicable |
Male and Female
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
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
260
1st name | |
Middle name | |
Last name | Kazumi Fukagawa |
Medical company "Keisyo Kai"
Chairperson of the BOD
4-33-12, Ryogoku, Sumida-ku, Tokyo
03-5600-6886
Kafun_Chiryo@quintiles.com
1st name | |
Middle name | |
Last name | Study support center |
Quintiles Transnational Japan K.K.
Medical & regulatory affairs division
3-4-30 Miyahara, Yodogawa-ku, Osaka
06-4807-9800
Kafun_Chiryo@quintiles.com
Medical company "Keisyo Kai"
Santen Pharmaceutical Co.,Ltd
Other
Japan
NO
2014 | Year | 01 | Month | 01 | Day |
Published
At the time of pollen dispersal peak, epinastine hydrochloride ophthalmic solution significantly controlled itch sensation, patient-reported outcomes, objective symptoms, total score of QOL (JACQLQ), and aggravation/severity of symptoms scored in QOL in the prior treatment group, compared with the standard treatment group. Based on the above result, it was considered that use of epinastine hydrochloride ophthalmic solution at early timing kept symptoms mild and is effective.
Completed
2013 | Year | 10 | Month | 08 | Day |
2014 | Year | 01 | Month | 01 | Day |
2014 | Year | 06 | Month | 30 | Day |
2013 | Year | 12 | Month | 27 | Day |
2015 | Year | 09 | Month | 08 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014846
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |