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

April 4, 2024 updated by: AJU Pharm Co., Ltd.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

396

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Test group(AJU-S56 5%)
QID(4 times in a day) for 24 Weeks after Randomization
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).
Other Names:
  • Test Group
Placebo Comparator: Placebo group(Vehicle)
QID(4 times in a day) for 24 Weeks after Randomization
Drug: 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).
Other Names:
  • Control Group

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AJU Pharm Co., Ltd.

Collaborators

GL Pharm Tech Corporation

Investigators

  • Principal Investigator: Hong Cheong, Ph.D, Wonju Severance Christian Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 10, 2023

Primary Completion (Estimated)

May 1, 2024

Study Completion (Estimated)

May 1, 2024

Study Registration Dates

First Submitted

February 27, 2024

First Submitted That Met QC Criteria

March 1, 2024

First Posted (Actual)

March 4, 2024

Study Record Updates

Last Update Posted (Actual)

April 8, 2024

Last Update Submitted That Met QC Criteria

April 4, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22DE30902

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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