Testing a new drug for patients with dry eye syndrome
The Purpose of This Clinical Study is to Prove That the Test Drug (AJU-S56 5%) is Superior to the Control Drug After 24 Weeks of Administration to Patients Who Have Moderate or Severe Dry Eye Syndrome
PHASE3 · AJU Pharm Co., Ltd. · NCT06291194
This study is testing a new eye drop medication to see if it can help people with moderate to severe dry eye syndrome feel better and improve their eye health.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 396 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | AJU Pharm Co., Ltd. (industry) |
| Locations | 1 site (Seoul) |
| Trial ID | NCT06291194 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the efficacy and safety of AJU-S56 5% in patients suffering from moderate to severe dry eye disease. Participants will be randomly assigned to receive either the test drug or a placebo vehicle. The study aims to assess improvements in symptoms and overall eye health through various clinical measures. The trial is designed to provide robust data on the effectiveness of AJU-S56 compared to standard treatment options.
Who should consider this trial
Good fit: Ideal candidates are adults over 19 years old with moderate to severe dry eye disease who meet specific clinical criteria.
Not a fit: Patients with significant eye diseases unrelated to dry eye syndrome or those requiring contact lenses may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly alleviate symptoms for patients suffering from dry eye syndrome.
How similar studies have performed: Other studies have shown promising results with similar interventions for dry eye syndrome, suggesting potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
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 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 wear contact lenses or need to wear contact lenses during study period * 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
Where this trial is running
Seoul
- AJU Pharm Co., Ltd. — Seoul, Korea, Republic of (RECRUITING)
Study contacts
- Study coordinator: JUNNGMIN LEE
- Email: ajuf13001@ajupharm.co.kr
- Phone: +82-02-2630-0700
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Dry Eye Syndromes, Dry eye