Efficacy and Safety of AJU-S56 in Dry Eye Syndrome Patients
Phase 2
Completed
- Conditions
- Dry Eye Syndromes
- Interventions
- Registration Number
- NCT06337981
- Lead Sponsor
- AJU Pharm Co., Ltd.
- Brief Summary
This study is planned to Evaluate the Efficacy and Safety of test drug (AJU-S56) compared to control drug(vehicle) in Patients with Dry Eye Disease.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 99
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 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 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Test group 1 (AJU-S56 5% and placebo) (AJU-S56 5%) and placebo(Vehicle), 1drop/1times, 3times in a day Test group 2 AJU-S56 5% (AJU-S56 5%), 1drop/1times, 6times in a day Comparator group Placebo(Vehicle) Placebo(Vehicle), 1drop/1times, 6times in a day
- Primary Outcome Measures
Name Time Method Total corneal staining score (TCSS) WEEK 4(Visit 4) (*Baseline, Visit 2 is performed in Day 0, Week 0) Total corneal staining score (TCSS) ≥4 at baseline (Total Max score : 15, bigger socre means worse outcome)
- Secondary Outcome Measures
Name Time Method LGCSS WEEK 2(Visit 3), 4(Visit 4), 8(Visit 5), 12(Visit 12) (*Baseline, Visit 2 is performed in Day 0, Week 0) Lissamine Green Conjunctival Staining Score(Total score : 0\~18)
TFBUT WEEK 2(Visit 3), 4(Visit 4), 8(Visit 5), 12(Visit 12) (*Baseline, Visit 2 is performed in Day 0, Week 0) Tear Film Break Up Time
Trial Locations
- Locations (1)
AJU Pharm Co., Ltd.
🇰🇷Seoul, Korea, Republic of