Clinical trial

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

Name

22DE30902

Description

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.

Trial arms

Trial start

2023-11-10

Estimated PCD

2024-05-01

Trial end

2024-05-01

Status

Recruiting

Phase

Early phase I

Treatment

AJU-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).

Arms:

Test group(AJU-S56 5%)

Other names:

Test Group

Placebo 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).

Arms:

Placebo group(Vehicle)

Other names:

Control Group

Size

396

Primary endpoint

Total corneal staining score (TCSS)

WEEK 4, 8, 12

Eligibility criteria

Inclusion Criteria: * 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. 1. TCSS (National eye institute (NEI) scale)≥ 4 2. Ocular discomfort score (ODS) ≥ 3 3. Schirmer test(without anesthesia) ≤ 10mm in 5 mins 4. Tear break-up time ≤ 6 secs * Written informed consent to participate in the trial Exclusion Criteria: * 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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 396, 'type': 'ESTIMATED'}}

Updated at

2024-04-08

1 organization

2 products

1 indication

Organization

Product

Indication

Product