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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

396 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-10

Study Completion Date

2024-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Dry Eye Syndromes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Test group(AJU-S56 5%)

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

Group Type EXPERIMENTAL

AJU-S56 5%

Intervention Type DRUG

After Randomization(Week 0), Participants will be administered with the durg, QID(4 times in a day, and 1 drop per each times) until end of trial(Week 24).

Placebo group(Vehicle)

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

Group Type PLACEBO_COMPARATOR

Placebo Group(Vehicle)

Intervention Type DRUG

After Randomization(Week 0), Participants will be administered with the durg, QID(4 times in a day, and 1 drop per each times) until end of trial(Week 24).

Interventions

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AJU-S56 5%

After Randomization(Week 0), Participants will be administered with the durg, QID(4 times in a day, and 1 drop per each times) until end of trial(Week 24).

Intervention Type DRUG

Placebo Group(Vehicle)

After Randomization(Week 0), Participants will be administered with the durg, QID(4 times in a day, and 1 drop per each times) until end of trial(Week 24).

Intervention Type DRUG

Other Intervention Names

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Test Group Control Group

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No