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

Last updated: April 4, 2024
Sponsor: AJU Pharm Co., Ltd.
Overall Status: Active - Recruiting

Phase

3

Condition

Sjogren's Syndrome

Dry Eye Disease

Eyelid Inflammation

Treatment

Placebo Group(Vehicle)

AJU-S56 5%

Clinical Study ID

NCT06291194
22DE30902
  • Ages > 19
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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

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 wearcontact lenses or need to wear contact lenses during study period
  • Those who have medical history with intraocular surgery 12months before screeningvisit
  • Use of corticosteroid, beta blocker and anticholinergic agent within 4 weeks
  • Participation in other studies within 4weeks of screening visit

Study Design

Total Participants: 396
Treatment Group(s): 2
Primary Treatment: Placebo Group(Vehicle)
Phase: 3
Study Start date:
November 10, 2023
Estimated Completion Date:
May 31, 2024

Connect with a study center

  • AJU Pharm Co., Ltd.

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Wonju Severance Christian Hospital

    Wŏnju,
    Korea, Republic of

    Site Not Available

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