Efficacy and Safety of SJP-0132 Eye Drops in Chinese Patients With Dry Eye Disease

Inclusion Criteria:

• Male or female patients aged between 18 and 70 at the time of the informed consent

• Outpatient patients

• The patient's self-described dry eye symptom is more than 6 months or has theclinical diagnosis certificate of dry eye in the past 6 months at the time of theinformed consent

• Tear film break-up time of <= 5 seconds at the beginning of screening and treatmentperiod

Exclusion Criteria:

• Patients who have previously used SJP-0132 eye drops

• Patients who participated in or are currently participating in or planned toparticipate in other clinical studies within three months prior to the start of thescreening period

• Patients who plan to wear corneal contact lenses between the beginning of thescreening period and the end of the treatment period

• Patients who have undergone eye surgery (including laser surgery) or planned toundergo any eye surgery during the study period within one year prior to thebeginning of the corneal transplantation surgery or screening period

• Any ophthalmic disease except for the dry eye (including eyeball or periocularinfection, allergic or proliferative eye disease) is present at the beginning of thescreening period and at the beginning of the treatment period. However, it does notinclude chronic eye disease patients who do not need treatment and may not becomeworse before the end of the treatment period

• Have known history of hypersensitivity or serious adverse reaction to any of thestudy drug ingredients

• Patients suffering from serious cardiovascular, respiratory, endocrine, digestive,urinary, blood, neurological, mental, ocular or peripheral malignancies (cured in orat the beginning of the screening period but not exceeding five years), at thebeginning of screening and treatment period

• A patient at the beginning of screening and at treatment period who has a positiveblood serum pregnancy test result or is in lactation, or a female patient who hasplanned pregnancy during the study period or has fertility but is unable to useeffective contraception during the study period, or a female partner of a malepatient who is unable to use effective contraception during the study

• Patients identified at the beginning of screening and treatment period asresearchers, research coordinators, researchers and immediate relatives of thepersons referred to above

• At the beginning of the screening and treatment period, investigators determine thatpatients who were unable to comply with the requirements of the program or wereunable to come to hospital on schedule (e.g. patients who planned to travel or stayin the field during the period prior to the end of the treatment period)

• At the beginning of the screening and treatment period, investigators decide thatthe patients who were not suitable for the trial were not suitable for the otherreasons

• Meet the other protocol-specified exclusion criteria