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NCT06337981 Clinical Trial

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

Dry Eye Syndromes Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06337981
Other study ID # 21DE20901
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date November 22, 2021
Est. completion date November 28, 2022

Study information
Verified date April 2024
Source AJU Pharm Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 99
Est. completion date November 28, 2022
Est. primary completion date June 14, 2022
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• (AJU-S56 5% and placebo)
(AJU-S56 5%) and placebo(Vehicle), 1drop/1times, 3times in a day
• AJU-S56 5%
(AJU-S56 5%), 1drop/1times, 6times in a day
• Placebo(Vehicle)
Placebo(Vehicle), 1drop/1times, 6times in a day

Locations
Country Name City State
Korea, Republic of AJU Pharm Co., Ltd. Seoul

Sponsors (2)
Lead Sponsor Collaborator
AJU Pharm Co., Ltd. GL Pharm Tech Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 LGCSS 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)
Secondary TFBUT 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)
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