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

Aju Pharm

Status and phase: Completed; Phase 2

Conditions: Dry Eye Syndromes

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT06337981

21DE20901

Details and patient eligibility

About

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.

Enrollment: 99 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. 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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99 participants in 3 patient groups, including a placebo group

Test group 1

Experimental group

Description:

(AJU-S56 5%) and placebo(Vehicle), 1drop/1times, 3times in a day

Treatment:

Drug: (AJU-S56 5% and placebo)

Test group 2

Experimental group

Description:

(AJU-S56 5%), 1drop/1times, 6times in a day

Treatment:

Drug: AJU-S56 5%

Comparator group

Placebo Comparator group

Description:

Placebo(Vehicle), 1drop/1times, 6times in a day

Treatment:

Drug: Placebo(Vehicle)