RECRUITINGPhase 3INTERVENTIONAL
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
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- 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 willing to sign a consent form to participate in the trial
Who Should NOT Join This Trial:
- 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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
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).
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).
Locations (1)
AJU Pharm Co., Ltd.
Seoul, South Korea