Clinical trial

A Phase 2 Multicenter, Randomized, Double-blinded, Placebo-controlled Trial to Evaluate the Efficacy and Safety of AJU-S56 in Patients With Dry Eye Disease

Name

21DE20901

Description

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

Trial arms

Trial start

2021-11-22

Estimated PCD

2022-06-14

Trial end

2022-11-28

Status

Completed

Phase

Early phase I

Treatment

(AJU-S56 5% and placebo)

(AJU-S56 5%) and placebo(Vehicle), 1drop/1times, 3times in a day

Arms:

Test group 1

Other names:

Test 1 group(AJU-S56 5% and placebo, each 1 drop/1time, 3times in a day)

AJU-S56 5%

(AJU-S56 5%), 1drop/1times, 6times in a day

Arms:

Test group 2

Other names:

Test 2 group(AJU-S56 5%, 1 drop/1time, 6times in a day)

Placebo(Vehicle)

Placebo(Vehicle), 1drop/1times, 6times in a day

Arms:

Comparator group

Other names:

Placebo group(Vehicle, 1 drop/1time, 6times in a day)

Size

Primary endpoint

Total corneal staining score (TCSS)

WEEK 4(Visit 4) (*Baseline, Visit 2 is performed in Day 0, Week 0)

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. TCSS (National eye institute (NEI) scale)≥ 4 Schirmer test(without anesthesia) ≤ 10mm in 5 mins 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 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': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 99, 'type': 'ACTUAL'}}

Updated at

2024-04-29

1 organization

2 products

1 indication

Organization

Product

Indication

Product