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RECRUITINGPHASE3

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

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

NCT06291194•AJU Pharm Co., Ltd.

View on ClinicalTrials.gov

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.

Eligibility

Age

19 - No limit years

Sex

ALL

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.
•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

Locations (1)

AJU Pharm Co., Ltd.

Seoul, South Korea

Key Dates

Start Date

November 10, 2023

Primary Completion Date

May 1, 2024

Completion Date

May 1, 2024

Last Updated

April 8, 2024

Enrollment

396

ESTIMATED participants

Conditions

Dry Eye Syndromes

Interventions

AJU-S56 5%

DRUG

Placebo Group(Vehicle)

DRUG

Contacts

JUNNGMIN LEE

CONTACT

+82-02-2630-0700 ajuf13001@ajupharm.co.kr

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 8, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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