Efficacy and Safety of AJU-S56 5% in Dry Eye Syndrome Patients

Aju Pharm

Status and phase: Enrolling; Phase 3

Conditions: Dry Eye Syndromes

Treatments: Drug: Placebo Group(Vehicle); Drug: AJU-S56 5%

Study type: Interventional

Funder types: Industry

Identifiers

NCT06291194

22DE30902

Details and patient eligibility

About

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.

Enrollment: 396 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

396 participants in 2 patient groups, including a placebo group

Test group(AJU-S56 5%)

Experimental group

Description:

QID(4 times in a day) for 24 Weeks after Randomization

Treatment:

Drug: AJU-S56 5%

Placebo group(Vehicle)

Placebo Comparator group

Description:

QID(4 times in a day) for 24 Weeks after Randomization

Treatment:

Drug: Placebo Group(Vehicle)