Dry Eye Disease
Conditions
Interventions
Administration of SJP-0154 or Placebo
Sponsors
Omatsu Kazunori
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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
Exclusion criteria
Exclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in dry eye symptoms | — |
Secondary
| Measure | Time frame |
|---|---|
| -Dry eye signs and symptoms -Safety | — |
Contacts
Public Contactdivision Clinical
Senju Pharmaceutical Co., Ltd.
Outcome results
None listed