JRCT ID: jRCT2031240351
Registered date:26/09/2024
Phase 3 Conjunctival Allergen Challenge Trial of NTa53
Basic Information
| Recruitment status | Recruiting |
|---|---|
| Health condition(s) or Problem(s) studied | Allergic Conjunctivitis |
| Date of first enrollment | 30/10/2024 |
| Target sample size | 44 |
| Countries of recruitment | |
| Study type | Interventional |
| Intervention(s) | NTa53, active drug and placebo administration, and allergen challenge |
Outcome(s)
| Primary Outcome | Efficacy (Ocular Itching Score and Conjunctival Redness Score) |
|---|---|
| Secondary Outcome |
Key inclusion & exclusion criteria
| Age minimum | >= 12age old |
|---|---|
| Age maximum | < 65age old |
| Gender | Both |
| Include criteria | -Provided signed, written informed consent. -Has a positive result from a Type I allergy test. |
| Exclude criteria | -Eye disease other than allergic conjunctivitis is present and requires treatment. -Other protocol-specified exclusion criteria may apply. |
Related Information
| Primary Sponsor | Hasunuma Tomoko |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | |
| Secondary ID(s) |
Contact
| Public contact | |
| Name | Takeshi Yonemichi |
| Address | 1-14-1 Yasuuchi, Yatsuo-machi, Toyama-city, Toyama, Japan Toyama Japan 939-2366 |
| Telephone | +81-76-455-3541 |
| clinical@nittomedic.co.jp | |
| Affiliation | Nitto Medic Co., Ltd. |
| Scientific contact | |
| Name | Tomoko Hasunuma |
| Address | 5-9-1 Shirokane,Minato-ku, Tokyo, Japan Tokyo Japan 108-8642 |
| Telephone | +81-3-5791-6350 |
| t-hasu@insti.kitasato-u.ac.jp | |
| Affiliation | Kitasato University Kitasato Institute Hospital |