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OpenTrials
Completed

NCT Number: NCT06337981

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

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.

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Key information

Conditions

Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

AJU Pharm Co., Ltd.

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

(AJU-S56 5% and placebo)

Drug

(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)

AJU-S56 5%

Drug

(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(Vehicle)

Drug

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

Other names: Placebo group(Vehicle, 1 drop/1time, 6times in a day)

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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)

  2. 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

Sponsors and collaborators

Lead sponsor

AJU Pharm Co., Ltd.

Industry

Collaborators

  • GL Pharm Tech Corporation

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 29, 2024
Registry last updated
Apr 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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