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
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 19
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Republic of Korea
AJU Pharm Co., Ltd.
RECRUITING
Seoul
Contact Information
Primary
JUNNGMIN LEE
ajuf13001@ajupharm.co.kr
+82-02-2630-0700
Time Frame
Start Date: 2023-11-10
Estimated Completion Date: 2024-05
Participants
Target number of participants: 396
Treatments
Experimental: Test group(AJU-S56 5%)
QID(4 times in a day) for 24 Weeks after Randomization
Placebo_comparator: Placebo group(Vehicle)
QID(4 times in a day) for 24 Weeks after Randomization
Related Therapeutic Areas
Sponsors
Collaborators: GL Pharm Tech Corporation
Leads: AJU Pharm Co., Ltd.