JRCT ID: jRCT2031220074
Registered date:19/05/2022
Phase 3 Study of STN1011402 ophthalmic cream in Patients With Seasonal Allergic Conjunctivitis
Basic Information
Recruitment status | Complete |
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Health condition(s) or Problem(s) studied | Allergic Conjunctivitis |
Date of first enrollment | 24/06/2022 |
Target sample size | 30 |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | First, 30 mg of 0.5% STN1011402 ophthalmic cream or placebo ophthalmic cream will be applied once a day, next, antigen will be induced 24 hours after its application. |
Outcome(s)
Primary Outcome | Efficacy (Subjective Ocular Symptom Score and Objective Findings Score), Safety |
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Secondary Outcome |
Key inclusion & exclusion criteria
Age minimum | >= 20age old |
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Age maximum | < 65age old |
Gender | Both |
Include criteria | Provided signed, written informed consent. Has a positive result for from a Type I allergy test. |
Exclude criteria | Eye disease other than allergic conjunctivitis is present and requires treatment. Females who are pregnant, nursing or planning a pregnancy, or females of childbearing potential who are not using a reliable method of contraception. |
Related Information
Primary Sponsor | Kayoko Sakamoto |
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Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) |
Contact
Public contact | |
Name | Sakamoto Kayoko |
Address | 4-20 Ofuka-cho, Kita-ku, Osaka, Japan Osaka Japan 530-8552 |
Telephone | +81-648029341 |
clinical@santen.co.jp | |
Affiliation | Santen pharmaceutical co.,ltd |
Scientific contact | |
Name | Sakamoto Kayoko |
Address | 4-20 Ofuka-cho, Kita-ku, Osaka, Japan Osaka Japan 530-8552 |
Telephone | +81-648029341 |
clinical@santen.co.jp | |
Affiliation | Santen pharmaceutical co.,ltd |