RecruitingPhase 3NCT06291194

Efficacy and Safety of AJU-S56 5% in Dry Eye Syndrome Patients

The Purpose of This Clinical Study is to Prove That the Test Drug (AJU-S56 5%) is Superior to the Control Drug After 24 Weeks of Administration to Patients Who Have Moderate or Severe Dry Eye Syndrome

Sponsor

AJU Pharm Co., Ltd.

Enrollment

396 participants

Start Date

Nov 10, 2023

Study Type

INTERVENTIONAL

Conditions

Dry Eye Syndromes

Summary

This study is planned to Evaluate the Efficacy and Safety of test drug (AJU-S56 5%) compared to control drug(vehicle) in Patients with Dry Eye Disease.

Eligibility

Min Age: 19 Years

Inclusion Criteria8

Male and Female who over 19 years old
Moderate to Severe Dry Eye Disease Patients
Must meet all criteria listed below at least in one eye or both eyes.
TCSS (National eye institute (NEI) scale)≥ 4
Ocular discomfort score (ODS) ≥ 3
Schirmer test(without anesthesia) ≤ 10mm in 5 mins
Tear break-up time ≤ 6 secs
Written informed consent to participate in the trial

Exclusion Criteria5

Those who have clinically significant eye disease not related to dry eye syndrome
Those who have worn contact lenses before 1week Screening visit or have to wear contact lenses or need to wear contact lenses during study period
Those who have medical history with intraocular surgery 12months before screening visit
Use of corticosteroid, beta blocker and anticholinergic agent within 4 weeks
Participation in other studies within 4weeks of screening visit

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Interventions

DRUGAJU-S56 5%

After Randomization(Week 0), Participants will be administered with the durg, QID(4 times in a day, and 1 drop per each times) until end of trial(Week 24).

DRUGPlacebo Group(Vehicle)

After Randomization(Week 0), Participants will be administered with the durg, QID(4 times in a day, and 1 drop per each times) until end of trial(Week 24).