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

Dry Eye Syndromes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06291194
• Other study ID #: 22DE30902
• Status: Recruiting
• Phase: Phase 3
• Start date: November 10, 2023
• Est. completion date: May 2024

Study information

• Verified date: April 2024
• Source: AJU Pharm Co., Ltd.
• Contact: JUNNGMIN LEE
• Phone: +82-02-2630-0700
• Email: ajuf13001[@]ajupharm.co.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 396
• Est. completion date: May 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Keratoconjunctivitis Sicca
• Syndrome

Intervention

Drug:
• AJU-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).
• Placebo 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).

Locations

Country	Name	City	State
Korea, Republic of	AJU Pharm Co., Ltd.	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
AJU Pharm Co., Ltd.	GL Pharm Tech Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total corneal staining score (TCSS)	TCSS =4 at baseline (Total Max score : 15)	WEEK 4, 8, 12
Secondary	LGCSS	Lissamine Green Conjunctival Staining Score(Total score : 0~18)	WEEK 4, 8, 12
Secondary	TFBUT	Tear Film Break Up Time	WEEK 4, 8, 12