NCT06291194
Recruiting
Phase 3
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
ConditionsDry Eye Syndromes
Overview
- Phase
- Phase 3
- Intervention
- AJU-S56 5%
- Conditions
- Dry Eye Syndromes
- Sponsor
- AJU Pharm Co., Ltd.
- Enrollment
- 396
- Locations
- 1
- Primary Endpoint
- Total corneal staining score (TCSS)
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
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.
- •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
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
Arms & Interventions
Test group(AJU-S56 5%)
QID(4 times in a day) for 24 Weeks after Randomization
Intervention: AJU-S56 5%
Placebo group(Vehicle)
QID(4 times in a day) for 24 Weeks after Randomization
Intervention: Placebo Group(Vehicle)
Outcomes
Primary Outcomes
Total corneal staining score (TCSS)
Time Frame: WEEK 4, 8, 12
TCSS ≥4 at baseline (Total Max score : 15)
Secondary Outcomes
- TFBUT(WEEK 4, 8, 12)
- LGCSS(WEEK 4, 8, 12)
Study Sites (1)
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