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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06291194

Enrollment

396

Registered

2024-03-04

Start date

2023-11-10

Completion date

2024-05-31

Last updated

2024-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry Eye Syndromes

Keywords

Dry eye

Brief 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.

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).

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Total corneal staining score (TCSS)	WEEK 4, 8, 12	TCSS ≥4 at baseline (Total Max score : 15)

Secondary

Measure	Time frame	Description
LGCSS	WEEK 4, 8, 12	Lissamine Green Conjunctival Staining Score(Total score : 0\ 18)
TFBUT	WEEK 4, 8, 12	Tear Film Break Up Time

Countries

South Korea

Contacts

Primary ContactJUNNGMIN LEE

ajuf13001@ajupharm.co.kr+82-02-2630-0700

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026