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
1 other identifier
interventional
396
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Nov 2023
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 10, 2023
CompletedFirst Submitted
Initial submission to the registry
February 27, 2024
CompletedFirst Posted
Study publicly available on registry
March 4, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2024
CompletedApril 8, 2024
April 1, 2024
6 months
February 27, 2024
April 4, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Total corneal staining score (TCSS)
TCSS ≥4 at baseline (Total Max score : 15)
WEEK 4, 8, 12
Secondary Outcomes (2)
LGCSS
WEEK 4, 8, 12
TFBUT
WEEK 4, 8, 12
Study Arms (2)
Test group(AJU-S56 5%)
EXPERIMENTALQID(4 times in a day) for 24 Weeks after Randomization
Placebo group(Vehicle)
PLACEBO COMPARATORQID(4 times in a day) for 24 Weeks after Randomization
Interventions
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).
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).
Eligibility Criteria
You may qualify if:
- 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
- Ocular discomfort score (ODS) ≥ 3
- Schirmer test(without anesthesia) ≤ 10mm in 5 mins
- Tear break-up time ≤ 6 secs
- Written informed consent to participate in the trial
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AJU Pharm Co., Ltd.lead
- GL Pharm Tech Corporationcollaborator
Study Sites (1)
AJU Pharm Co., Ltd.
Seoul, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 27, 2024
First Posted
March 4, 2024
Study Start
November 10, 2023
Primary Completion
May 1, 2024
Study Completion
May 1, 2024
Last Updated
April 8, 2024
Record last verified: 2024-04