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

NCT06337981 — Phase 2, Completed, 99 participants, AJU Pharm Co., Ltd.

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

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

Registry	NCT06337981
Status	Completed
Phase	Phase 2
Study type	Interventional; randomized, parallel, masking: quadruple, treatment
Enrollment	99 (Actual)
Sponsor	AJU Pharm Co., Ltd. (Industry); collaborators: GL Pharm Tech Corporation
Conditions	Dry Eye Syndromes
Interventions	(AJU-S56 5% and placebo), AJU-S56 5%, Placebo(Vehicle) (Drug)
Dates	start 2021-11-22, primary completion 2022-06-14, completion 2022-11-28, first posted 2024-03-29, last updated 2024-04-29
Locations	1 site in South Korea

-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.

Expand all sections · Collapse all

+Arms and interventions

Arm	Type	Interventions	Description
Test group 1	Experimental	Drug: (AJU-S56 5% and placebo)	(AJU-S56 5%) and placebo(Vehicle), 1drop/1times, 3times in a day
Test group 2	Experimental	Drug: AJU-S56 5%	(AJU-S56 5%), 1drop/1times, 6times in a day
Comparator group	Placebo comparator	Drug: Placebo(Vehicle)	Placebo(Vehicle), 1drop/1times, 6times in a day

(AJU-S56 5% and placebo) (Drug), also known as Test 1 group(AJU-S56 5% and placebo, each 1 drop/1time, 3times in a day): (AJU-S56 5%) and placebo(Vehicle), 1drop/1times, 3times in a day
AJU-S56 5% (Drug), also known as Test 2 group(AJU-S56 5%, 1 drop/1time, 6times in a day): (AJU-S56 5%), 1drop/1times, 6times in a day
Placebo(Vehicle) (Drug), also known as Placebo group(Vehicle, 1 drop/1time, 6times in a day): Placebo(Vehicle), 1drop/1times, 6times in a day

+Outcome measures

Primary outcomes

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 outcomes

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

+Eligibility

Sex: All, ages: 19 Years to any

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

+Locations (1)

Facility	City	Country	Status
AJU Pharm Co., Ltd.	Seoul	South Korea