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
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.
- TCSS (National eye institute (NEI) scale)≥ 4
- Ocular discomfort score (ODS) ≥ 3
- Schirmer test(without anesthesia) ≤ 10mm in 5 mins
- 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 ofActive - Recruiting
Wonju Severance Christian Hospital
Wŏnju,
Korea, Republic ofSite Not Available
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.