JRCT ID: jRCT2031220392
Registered date:08/12/2022
Long-term Study of SJP-0132 in Patients with Dry Eye Disease
Basic Information
Recruitment status | Complete |
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Health condition(s) or Problem(s) studied | Dry Eye Disease |
Date of first enrollment | 25/01/2023 |
Target sample size | 150 |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | Administer SJP-0132 as an eye drop to participants with dry eye disease |
Outcome(s)
Primary Outcome | Safety |
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Secondary Outcome | Dry eye signs and symptoms |
Key inclusion & exclusion criteria
Age minimum | >= 18age old |
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Age maximum | Not applicable |
Gender | Both |
Include criteria | - Aged over 18 years at the time of the informed consent (any gender) - Live in Japan - Have continuous subjective symptoms of dry eye disease - Tear film break-up time of <= 5 seconds - Meet the other protocol-specified inclusion criteria may apply |
Exclude criteria | - Unable to discontinue wearing contact lens during the study - Have a history of, or scheduled corneal transplantation during the study - Have a history of, or scheduled permanent punctal occlusion during the study - Have used or anticipates use of a punctal plug during the study - Have a history of, or scheduled ocular surface surgery during the study - Have ophthalmic disease other than dry eye disease - Have disease that affects subjective symptoms of dry eye - Have known history of hypersensitivity or serious adverse reaction to any of the study drug ingredients - Unable to discontinue any ophthalmic medicines including OTC, except test drug for ophthalmic examination during the study - Female participant who is pregnant, potentially pregnant, lactating or intents to become pregnant. And unable to obtain a consent to practice adequate contraception during the study - Male participant who does not agree to practice adequate contraception and not to donate sperm during the study - Have judged that it is inappropriate to participate in this study by investigator - Meet the other protocol-specified exclusion criteria |
Related Information
Primary Sponsor | Omatsu Kazunori |
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Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) |
Contact
Public contact | |
Name | division development Clinical |
Address | 6-4-3, Minatojima-Minamimachi, Chuo-ku, Kobe, Hyogo Hyogo Japan 650-0047 |
Telephone | +81-78-777-1018 |
senju-clinicaltrials@senju.co.jp | |
Affiliation | Senju Pharmaceutical Co., Ltd. |
Scientific contact | |
Name | Kazunori Omatsu |
Address | 6-4-3, Minatojima-Minamimachi, Chuo-ku, Kobe, Hyogo Hyogo Japan 650-0047 |
Telephone | +81-78-777-1018 |
senju-clinicaltrials@senju.co.jp | |
Affiliation | Senju Pharmaceutical Co., Ltd. |