JRCT ID: jRCT2031240171
Registered date:18/06/2024
A phase 2a study assessing the efficacy and safety of STN1010905 ophthalmic suspension in subjects with MGD
Basic Information
Recruitment status | Recruiting |
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Health condition(s) or Problem(s) studied | MGD (Meibomian Gland Dysfunction) |
Date of first enrollment | 01/07/2024 |
Target sample size | 120 |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | - Screening period : Artificial tear (BID, Both eyes) - Treatment period : High dose STN1010905 ophthalmic suspension, Low dose STN1010905 ophthalmic suspension or Placebo (BID, Both eyes) |
Outcome(s)
Primary Outcome | Evaluation of meibomian gland by idra |
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Secondary Outcome |
Key inclusion & exclusion criteria
Age minimum | >= 18age old |
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Age maximum | Not applicable |
Gender | Both |
Include criteria | - Outpatient - Diagnosed as MGD based on the guideline - Having ocular symptoms |
Exclude criteria | - Ocular disease which needs treatment expect MGD and dry eye - Requires contact lenses wear during the study - Any decision by the Investigator to terminate a subject in screening |
Related Information
Primary Sponsor | Migita Yukie |
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Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) |
Contact
Public contact | |
Name | Yukie Migita |
Address | 4-20 Ofuka-cho, Kita-ku, Osaka, Japan Osaka Japan 530-8552 |
Telephone | +81-6-4802-9341 |
clinical@santen.co.jp | |
Affiliation | Santen pharmaceutical co.,ltd |
Scientific contact | |
Name | Yukie Migita |
Address | 4-20 Ofuka-cho, Kita-ku, Osaka, Japan Osaka Japan 530-8552 |
Telephone | +81-6-4802-9341 |
clinical@santen.co.jp | |
Affiliation | Santen pharmaceutical co.,ltd |