Evaluating HUC3-053 for treating dry eye syndrome
A Multicenter, Randomized, Double-blinded, Non-inferiority Phase 3 Study to Evaluate the Efficacy and Safety of HUC3-053 Compared with Hyalein Mini Eye Drops in Patients with Dry Eye Syndrome
This study is testing a new treatment called HUC3-053 for people with dry eye syndrome to see if it works as well as the standard eye drops they usually use.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 280 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Huons Co., Ltd. Industry-sponsored |
| Locations | 1 site (Seoul, Jongno-gu) |
| Trial ID | NCT06388070 on ClinicalTrials.gov |
What this trial studies
This multi-center, randomized, double-blinded, non-inferiority study aims to assess the efficacy and safety of HUC3-053 in patients suffering from dry eye syndrome. After a 2-week run-in period where all participants receive a rescue drug, they will be randomly assigned to receive either HUC3-053 or Hyalein Mini Drops for 12 weeks, administered bilaterally five to six times a day. The study will measure various clinical outcomes to determine the effectiveness of HUC3-053 compared to the standard treatment.
Who should consider this trial
Good fit: Ideal candidates are adults over 19 with persistent symptoms of dry eye disease for at least three months and specific clinical test results indicating moderate to severe dry eye.
Not a fit: Patients with significant ocular disorders or those currently using medications that affect dry eye symptoms may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new effective option for patients suffering from dry eye syndrome.
How similar studies have performed: Other studies have shown success with similar approaches in treating dry eye syndrome, indicating a promising avenue for HUC3-053.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age over 19 * Volunteer who have had more than one symptom of dry eye disease for at least 3 month before screening visit. * Corneal staining score(Oxford grading) ≥ 2 and Schirmer test ≤ 10mm/5min (If Schirmer test = 0mm/5min, Nasal stimulation schirmer test ≥ 3mm/5min) and TBUT test ≤10 and OSDI (Ocular Surface Disease Index) ≥ 23 in at least one of both eyes * Best corrected visual acuity ≥ 0.2 in both eyes at Screening and Randomization Visit Exclusion Criteria: * The patients with clinically significant ocular disorders affected the test result Current or recent patients used dry eye syndrome medications (topical or systemic) that may affect the status * SBP ≥140mmHg or DBP ≥ 90mmHg or HbA1c\>9% * Wearing contact lenses within 72 hr of screening visit * Pregnancy or Breastfeeding
Where this trial is running
Seoul, Jongno-gu
- Gangbuk Samsung Hospital — Seoul, Jongno-gu, Korea, Republic of (Recruiting)
Study contacts
- Principal investigator: Chul Young Choi — Gangbuk Samsung Hospital
- Study coordinator: Mi Ae Leem
- Email: maleem@huons.com
- Phone: +82-70-7492-6091
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.