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

April 26, 2024 updated by: AJU Pharm Co., Ltd.

A Phase 2 Multicenter, Randomized, Double-blinded, Placebo-controlled Trial to Evaluate the Efficacy and Safety of AJU-S56 in Patients With Dry Eye Disease

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

99

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Test group 1
(AJU-S56 5%) and placebo(Vehicle), 1drop/1times, 3times in a day
Drug: (AJU-S56 5% and placebo)
(AJU-S56 5%) and placebo(Vehicle), 1drop/1times, 3times in a day
Other Names:
  • Test 1 group(AJU-S56 5% and placebo, each 1 drop/1time, 3times in a day)
Experimental: Test group 2
(AJU-S56 5%), 1drop/1times, 6times in a day
Drug: AJU-S56 5%
(AJU-S56 5%), 1drop/1times, 6times in a day
Other Names:
  • Test 2 group(AJU-S56 5%, 1 drop/1time, 6times in a day)
Placebo Comparator: Comparator group
Placebo(Vehicle), 1drop/1times, 6times in a day
Drug: Placebo(Vehicle)
Placebo(Vehicle), 1drop/1times, 6times in a day
Other Names:
  • Placebo group(Vehicle, 1 drop/1time, 6times in a day)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total corneal staining score (TCSS)
Time Frame: 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)
WEEK 4(Visit 4) (*Baseline, Visit 2 is performed in Day 0, Week 0)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
LGCSS
Time Frame: 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)
WEEK 2(Visit 3), 4(Visit 4), 8(Visit 5), 12(Visit 12) (*Baseline, Visit 2 is performed in Day 0, Week 0)
TFBUT
Time Frame: 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
WEEK 2(Visit 3), 4(Visit 4), 8(Visit 5), 12(Visit 12) (*Baseline, Visit 2 is performed in Day 0, Week 0)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AJU Pharm Co., Ltd.

Collaborators

GL Pharm Tech Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 22, 2021

Primary Completion (Actual)

June 14, 2022

Study Completion (Actual)

November 28, 2022

Study Registration Dates

First Submitted

March 24, 2024

First Submitted That Met QC Criteria

March 24, 2024

First Posted (Actual)

March 29, 2024

Study Record Updates

Last Update Posted (Actual)

April 29, 2024

Last Update Submitted That Met QC Criteria

April 26, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21DE20901

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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