Evaluating a new eye drop for dry eye disease
A Phase 3, Randomized, Double-Masked, Vehicle-controlled, Multi-center Study Evaluating the Safety and Efficacy of 5% VVN001 in Chinese Subjects With Dry Eye Disease
This study is testing a new eye drop for dry eye disease to see if it can help people aged 30 to 80 feel better and improve their eye health.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 700 (estimated) |
| Ages | 30 Years to 80 Years |
| Sex | All |
| Sponsor | VivaVision Biotech, Inc Industry-sponsored |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT06360133 on ClinicalTrials.gov |
What this trial studies
This Phase 3 clinical trial is a randomized, double-masked, vehicle-controlled study aimed at assessing the safety and efficacy of a 5% VVN001 Ophthalmic Solution in patients suffering from dry eye disease. Conducted in multiple centers, the trial will compare the new treatment against a placebo vehicle in Chinese subjects aged 30 to 80 who have a documented history of dry eye. Participants will be monitored for improvements in eye dryness symptoms and overall eye health throughout the study duration.
Who should consider this trial
Good fit: Ideal candidates are Chinese individuals aged 30 to 80 with a history of dry eye disease who have been using artificial tears recently.
Not a fit: Patients with uncontrolled glaucoma or known hypersensitivity to the study medication will not benefit from this trial.
Why it matters
Potential benefit: If successful, this treatment could significantly alleviate symptoms of dry eye disease and improve patients' quality of life.
How similar studies have performed: Other studies have shown promise in treating dry eye disease with similar ophthalmic solutions, indicating a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Provided written informed consent prior to any study-related procedures. * Are between 30 and 80 years of age. * Have a history of dry eye disease in both eyes. * Have been using artificial tears within 30 days of the screening visit * Have an Eye dryness score ≥50 (0-100 point VAS) * Have ongoing dry eye disease in the same eye or both eyes, as defined by all of the following criteria in the study eye and the same eye at Visit 1 and Visit 2: 1) total CFS (tCFS) score ≥6; 2) any subregion CS score ≥2.5; 3) Schirmer score (without anesthesia) ≥1 and ≤7 mm/5 min. * Have a BCVA in the study eye of ≥4.3 (Standard for Logarithmic Visual Acuity Charts, 5-mark record). Exclusion Criteria: * Have a known hypersensitivity or contraindication to the IP or components of IP. * Have history of uncontrolled glaucoma, IOP over 21 mmHg in either eye at the screening visit or are being treated with eye drops for glaucoma in the study eye. Or the subject has had laser or surgery for glaucoma in the study eye within 90 days of the study. * Woman of childbearing potential (WOCP) who are pregnant, lactating, or preparing for pregnant.
Where this trial is running
Shanghai, Shanghai Municipality
- Eye & Ent Hospital of Fudan University — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Principal investigator: Xinghuai Sun — Eye & ENT Hospital of Fudan University
- Study coordinator: Caroline Lu
- Email: caroline.lu@vivavisionbio.com
- Phone: 86-18816562189
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.