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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06337981

Enrollment

Registered

2024-03-29

Start date

2021-11-22

Completion date

2022-11-28

Last updated

2024-04-29

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) compared to control drug(vehicle) in Patients with Dry Eye Disease.

Interventions

DRUG(AJU-S56 5% and placebo)

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

DRUGAJU-S56 5%

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

DRUGPlacebo(Vehicle)

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

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. 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

Design outcomes

Primary

Measure	Time frame	Description
Total corneal staining score (TCSS)	WEEK 4(Visit 4) (*Baseline, Visit 2 is performed in Day 0, Week 0)	Total corneal staining score (TCSS) ≥4 at baseline (Total Max score : 15, bigger socre means worse outcome)

Secondary

Measure	Time frame	Description
LGCSS	WEEK 2(Visit 3), 4(Visit 4), 8(Visit 5), 12(Visit 12) (*Baseline, Visit 2 is performed in Day 0, Week 0)	Lissamine Green Conjunctival Staining Score(Total score : 0\ 18)
TFBUT	WEEK 2(Visit 3), 4(Visit 4), 8(Visit 5), 12(Visit 12) (*Baseline, Visit 2 is performed in Day 0, Week 0)	Tear Film Break Up Time

Countries

South Korea

Outcome results

None listed

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