Dry Eye Disease
Conditions
Interventions
Administer SJP-0132 or Placebo as an eye drop to participants with dry eye disease
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