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

NCT06337981 | Completed Phase 2

• 1 other identifier: 21DE20901
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dry Eye Syndromes

Keywords

Dry eye

Outcome Measures

Primary Outcomes (1)

• Total corneal staining score (TCSS)

  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 Outcomes (2)

• LGCSS

  WEEK 2(Visit 3), 4(Visit 4), 8(Visit 5), 12(Visit 12) (*Baseline, Visit 2 is performed in Day 0, Week 0)

• TFBUT

  WEEK 2(Visit 3), 4(Visit 4), 8(Visit 5), 12(Visit 12) (*Baseline, Visit 2 is performed in Day 0, Week 0)

Study Arms (3)

Test group 1

EXPERIMENTAL

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

Drug: (AJU-S56 5% and placebo)

Test group 2

EXPERIMENTAL

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

Drug: AJU-S56 5%

Comparator group

PLACEBO COMPARATOR

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

Drug: Placebo(Vehicle)

Interventions

(AJU-S56 5% and placebo) DRUG

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

Also known as: Test 1 group(AJU-S56 5% and placebo, each 1 drop/1time, 3times in a day)

Test group 1

AJU-S56 5% DRUG

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

Also known as: Test 2 group(AJU-S56 5%, 1 drop/1time, 6times in a day)

Test group 2

Placebo(Vehicle) DRUG

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

Also known as: Placebo group(Vehicle, 1 drop/1time, 6times in a day)

Comparator group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AJU Pharm Co., Ltd.: lead
• GL Pharm Tech Corporation: collaborator

Study Sites (1)

AJU Pharm Co., Ltd.

Seoul, South Korea

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2024
• First Posted: March 29, 2024
• Study Start: November 22, 2021
• Primary Completion: June 14, 2022
• Study Completion: November 28, 2022
• Last Updated: April 29, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)