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

Senju Pharmaceutical Science & Technology (Beijing) Co., Ltd.

Status and phase: Enrolling; Phase 3

Conditions: Dry Eye

Treatments: Drug: Placebo; Drug: SJP-0132

Study type: Interventional

Funder types: Industry

Identifiers

NCT06717152

CTR20244132 (Registry Identifier)

SJP-0132/3-03

Details and patient eligibility

About

This study will evaluate the safety and efficacy of SJP-0132 in Chinese Patients with Dry Eye.

Patients will be randomly assigned to receive either SJP-0132 or placebo.

Enrollment: 400 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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 the clinical diagnosis certificate of dry eye in the past 6 months at the time of the informed consent
• Tear film break-up time of <= 5 seconds at the beginning of screening and treatment period

Exclusion criteria

• Patients who have previously used SJP-0132 eye drops
• Patients who participated in or are currently participating in or planned to participate in other clinical studies within three months prior to the start of the screening period
• Patients who plan to wear corneal contact lenses between the beginning of the screening period and the end of the treatment period
• Patients who have undergone eye surgery (including laser surgery) or planned to undergo any eye surgery during the study period within one year prior to the beginning of the corneal transplantation surgery or screening period
• Any ophthalmic disease except for the dry eye (including eyeball or periocular infection, allergic or proliferative eye disease) is present at the beginning of the screening period and at the beginning of the treatment period. However, it does not include chronic eye disease patients who do not need treatment and may not become worse before the end of the treatment period
• Have known history of hypersensitivity or serious adverse reaction to any of the study drug ingredients
• Patients suffering from serious cardiovascular, respiratory, endocrine, digestive, urinary, blood, neurological, mental, ocular or peripheral malignancies (cured in or at the beginning of the screening period but not exceeding five years), at the beginning of screening and treatment period
• A patient at the beginning of screening and at treatment period who has a positive blood serum pregnancy test result or is in lactation, or a female patient who has planned pregnancy during the study period or has fertility but is unable to use effective contraception during the study period, or a female partner of a male patient who is unable to use effective contraception during the study
• Patients identified at the beginning of screening and treatment period as researchers, research coordinators, researchers and immediate relatives of the persons referred to above
• At the beginning of the screening and treatment period, investigators determine that patients who were unable to comply with the requirements of the program or were unable to come to hospital on schedule (e.g. patients who planned to travel or stay in the field during the period prior to the end of the treatment period)
• At the beginning of the screening and treatment period, investigators decide that the patients who were not suitable for the trial were not suitable for the other reasons
• Meet the other protocol-specified exclusion criteria

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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400 participants in 2 patient groups, including a placebo group

SJP-0132

Experimental group

Description:

The participants receive placebo for 2 weeks in run-in period, then SJP-0132 for 8 weeks in treatment period.

Treatment:

Drug: SJP-0132

Drug: Placebo

Placebo

Placebo Comparator group

Description:

The participants receive placebo for 2 weeks in run-in period, then placebo for 8 weeks in treatment period.

Treatment:

Drug: Placebo