NCT06291194 Efficacy and Safety of AJU-S56 5% in Dry Eye Syndrome Patients
| NCT ID | NCT06291194 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | AJU Pharm Co., Ltd. |
| Condition | Dry Eye Syndromes |
| Study Type | INTERVENTIONAL |
| Enrollment | 396 participants |
| Start Date | 2023-11-10 |
| Primary Completion | 2024-05 |
Trial Parameters
Eligibility Fast-Check
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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.
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. 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