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New treatment option for Dry Eye
Official title Study of 5% VVN001 Ophthalmic Solution in Dry Eye Disease
ClinicalTrials.gov ID: NCT06360133
What this study is testing
What is VVN001 Ophthalmic Solution, 5%?
VVN001 Ophthalmic Solution, 5% is an investigational medicine, being studied as a potential treatment for dry eye.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a Phase 3, randomized, double-Masked, vehicle-controlled, multi-center study designed to evaluate the safety and efficacy of 5% VVN001 Ophthalmic Solution versus vehicle in Chinese subjects with dry eye disease.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 30 to 80
You may be able to join if
- 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)
You likely can't join if
- 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...
- Woman of childbearing potential (WOCP) who are pregnant, lactating, or preparing for pregnant.
See the full eligibility 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...
- Have a BCVA in the study eye of ≥4.3 (Standard for Logarithmic Visual Acuity Charts, 5-mark record).
- 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...
- Woman of childbearing potential (WOCP) who are pregnant, lactating, or preparing for pregnant.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 30 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.