RECRUITINGPhase 3INTERVENTIONAL
Study of 5% VVN001 Ophthalmic Solution in 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
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- Provided written willing to sign a consent form 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).
Who Should NOT Join This Trial:
- 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.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.
Treatments Being Tested
DRUG
VVN001 Ophthalmic Solution, 5%
VVN001 Ophthalmic Solution, 5%
DRUG
VVN001 Ophthalmic Solution, Vehicle
VVN001 Ophthalmic Solution, Vehicle
Locations (1)
Eye & Ent Hospital of Fudan University
Shanghai, Shanghai Municipality, China