NCT03723798

Clinical Study to Investigate the Efficacy and Safety of Orally Administered SA001 in Patients With Dry Eye Syndrome.

A Multicenter, Placebo Controlled, 4-group Parallel Randomized, Double Blind, Phase II Study to Evaluate the Efficacy and Safety of Orally Administered SA001 in Patients With Dry Eye Syndrome.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 172 (actual)
• Sponsor: Samjin Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 19 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 2, multicenter, double-blind, placebo control, randomized study to evaluate the efficacy and safety of orally administered SA001 compared to placebo in patients with Dry Eye Syndrome. The clinical trial consists of a wash-out period of 14 days, a treatment period of 12 weeks, and a follow-up period of 1 week after administration of the Investigational Product. If the subject voluntarily signs the informed consent form(ICF), the investigator conducts screening tests and check medical history to evaluate the subject's suitability. As a result of the screening test, eligible subjects should stop using the prior medication for dry eye syndrome during the 14 days of observation period, and if necessary, subjects can use rescue drug(artificial tears) for the first 11 days, and then discontinue all eye drops including rescue drug(artificial tears) for 3 days. And all of these subjects will be randomized in a 1:1:1:1 ratio to receive 3 different doses of investigational product (SA001 or placebo) everyday for 12 weeks. During the treatment period, If necessary, subjects can use the rescue drug (artificial tears), and the number of administration of rescue drug is limited to 3 times a day, and when used, the administration time should be recorded in the subject's diary. Subjects should visit to the study site on 2, 4, 8 and 12 weeks after starting dosing investigational product. Efficacy evaluation results are collected from both eyes, and the primary evaluation variable is analyzed using the test results collected from 'Worse eye' (the eye with the worse keratoconjunctival staining result among both eyes). Worse eye will be determined at the baseline visit and, if the results of both eyes are the same, the test result of the left eye is used.

Conditions

• Dry Eye Syndrome

Interventions

Type	Name	Description
DRUG	SA001 Low dose	3 tablets b.i.d for 12 weeks
DRUG	SA001 Mid dose	3 tablets b.i.d for 12 weeks
DRUG	SA001 High dose	3 tablets b.i.d for 12 weeks
DRUG	Placebo	3 tablets b.i.d for 12 weeks

Timeline

• Start date: 2017-11-08
• Primary completion: 2018-10-01
• Completion: 2018-10-08
• First posted: 2018-10-30
• Last updated: 2022-03-18

Locations

1 site across 1 country: South Korea