Efficacy and Safety of AJU-S56 5% in Dry Eye Syndrome Patients

Phase 3

Recruiting

• Conditions: Dry Eye Syndromes
• Interventions: Drug: Placebo Group(Vehicle); Drug: AJU-S56 5%

• Registration Number: NCT06291194
• Lead Sponsor: AJU Pharm Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-10
• Study First Submitted: 2024-02-27
• Study First Submitted QC: 2024-03-01
• Study First Posted: 2024-03-04
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-04
• Last Update Posted: 2024-04-08
• Primary Completion: 2024-05
• Study Completion: 2024-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 396

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo group(Vehicle)	Placebo Group(Vehicle)	QID(4 times in a day) for 24 Weeks after Randomization
Test group(AJU-S56 5%)	AJU-S56 5%	QID(4 times in a day) for 24 Weeks after Randomization

Primary Outcome Measures

Name	Time	Method
Total corneal staining score (TCSS)	WEEK 4, 8, 12	TCSS ≥4 at baseline (Total Max score : 15)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

AJU Pharm Co., Ltd.; 🇰🇷 Seoul, Korea, Republic of